process development scientist

Bayer

<p></p><div><p><b>At Bayer we&rsquo;re visionaries, driven to solve the world&rsquo;s toughest challenges and striving for a world where ,Health for all, Hunger for none&rsquo; is no longer a dream, but a real possibility. We&rsquo;re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining &lsquo;impossible&rsquo;. There are so many reasons to join us. If you&rsquo;re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there&rsquo;s only one choice.</b></p><br>
<p></p>
<p><b>
Process Development Scientist II</b></p><p></p><p><b><br>
POSITION PURPOSE:</b></p><br>
<p></p>
<p>
Process Development Scientist-II with some supervision from the Chemical Development Lead focuses on route scouting and Chemical Process Development of Bayers' existing and pipeline crop protective agents. Collaborates with all internal and external functional teams. The job holders ensure all the experimental work is done following the highest safety standards and document the generated data in the Electronic Lab Notebook. The successful candidate will work within an interdisciplinary and cross-divisional team in the Crop Protection Innovation organization.</p><br>
<p></p>
<p><b>
TASKS AND RESPONSIBILITIES:</b></p><br>
<p></p>
<ul>
<li>Conduct process chemistry research as an individual contributor, which includes, but is not limited to, research on inventing new synthetic routes to agrochemicals by route scouting, process optimization, safety evaluation, high throughput screening and chemo/biocatalytic reaction discovery and optimization. Invent synthetic routes and develop safe, robust, and cost-effective processes to manufacture Crop Protection Agents
</li><li>Contribute to the Chemical Development Process by conducting laboratory experiments by own hand and providing experimental results, technical updates, documentation, data interpretation, recommendations for process optimization, etc.</li>
<li>With the help of the Process Engineer optimize unit operations Investigate optimization, generate safety and process engineering data required for scale-up of chemical reactions</li>
<li>Assist in the design, planning and execution of multi-step experimental studies guided by risk assessment to deliver safe, efficient, robust manufacturing processes.</li>
<li>Collaborate within project teams by working closely with analytical chemists, process engineers, pilot plant team and project managers within the Crop Protection Innovation organization.</li>
<li>Support Chemical Development Lead in preparation of SOPs, and other relevant documents (e.g. Technical Reports, Presentations, Technology Dossier).</li>
<li>Work independently or in a team in advancing projects and studies within required timelines</li><br>
</ul>
<p></p><ul><li>Follow all company, site and laboratory Environmental, Health and Safety (EHS)-related protocols, processes, guidelines and SOPs. Actively participate in EHS discussions with peers and management for continuous improvement of EHS practices.</li></ul><br>
<p></p>
<p><b>
KEY WORKING RELATIONS:</b></p><br>
<p></p>
<div>
<ul><li><b>Internal</b></li></ul>
</div><ul><li>Crop Protection Innovation Team</li>
<li>Analytical Chemist from
</li><li>Pilot Plant Team</li>
<li>AIM Production Team</li>
<li>AIM Analytical team at Vapi</li></ul><br>
<div></div>
<div>
<ul><li><b>External</b></li></ul>
</div><ul><li>Coordinate with Various Vendors and Engineers for instrument installation/maintenance activities</li></ul><br>
<div></div>
<div><b>
WHO YOU ARE:</b></div><br>
<div></div>
<ul>
<li>M.Sc. in Organic Chemistry with more than 10 years of Chemical Process Development or PhD/PDF in Organic chemistry with specialization in total synthesis, reaction methodology, or mechanistic studies, with more than 3 years of experience.</li>
<li>Comprehensive and state-of-the-art knowledge of modern synthetic methodologies as well as a basic understanding of organic reaction mechanisms and retrosynthesis.</li>
<li>Strong problem-solving and troubleshooting abilities on a day-to-day basis with minimum supervision</li>
<li>Strong understanding of small molecule analysis including chromatographic and spectroscopic techniques and structure elucidation by NMR and Mass Spectroscopy is required
</li><li>Prior experience working with Process Analytical Technologies (PAT) for process understanding and process control is desirable
</li><li>Demonstrated ability to work within a dynamic and interdisciplinary environment to achieve results</li>
<li>Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects to meet aggressive timeline
</li><li>Ability to work in the shifts
</li><li>Self-motivated to learn and develop within the organization</li></ul><br>
<p></p>
<div>
<div><p><b>Ever feel burnt out by bureaucracy? Us too. That&rsquo;s why we&rsquo;re changing the way we work&mdash; for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here </b><b>https://www.bayer.com/en/strategy/strategy</b></p><br>
<p></p>
<p><b>
Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext.</b></p><br>
<p></p>
<p><b>
Please don&rsquo;t rely upon any unsolicited email from email addresses not ending with domain name &ldquo;bayer.com&rdquo; or job advertisements referring you to an email address that does not end with &ldquo;bayer.com&rdquo;.</b></p></div><br>
</div><div>
<div></div><div><br>
<div><div><b>YOUR APPLICATION</b></div></div><br>
<div></div>
<div>
</div><br>
<div></div><div><div><p>Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.</p></div><br>
<p></p>
</div><br>
</div></div><div></div><div><div><br>
<div><div><b>Location:</b></div> <div>India : Gujarat : Vapi</div>
</div><br>
<div></div><div><div><b>Division:</b></div> <div>Crop Science</div>
</div><br>
<div></div><div><div><b>Reference Code:</b></div> <div>856306</div><br>
<div></div>
<div></div>
</div><br>
</div></div><div></div><div><div><br>
<br>
<div><div><b>Contact Us</b></div>
</div><br>
<br>
<div></div><div><div>+ 022-25311234</div></div></div></div></div>

Process Development Scientist II

PI Health Sciences Ltd

<div>
 <p>
  <strong>
   Job Title: Research Scientist / Senior Research Scientist &ndash; Process R&amp;D
  </strong>
 </p>
 <p>
  <strong>
   Department:
  </strong>
  R&amp;D &ndash; Process Development
 </p>
 <p>
  <strong>
   Industry:
  </strong>
  CDMO / API
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Purpose of the Role:
  </strong>
 </p>
 <p>
  To lead and execute the development, optimization, and scale-up of robust, cost-effective, and regulatory-compliant chemical processes for Active Pharmaceutical Ingredients (APIs) and intermediates, ensuring smooth technology transfer from lab to kilo lab and manufacturing.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key Responsibilities
  </strong>
 </p>
 <p>
  <strong>
   1. Strategic Responsibilities
  </strong>
 </p>
 <ul>
  <li>
   Drive innovation by designing synthetic routes that align with project timelines and regulatory requirements.
  </li>
  <li>
   Contribute to technology differentiation strategies that enhance the CDMO&rsquo;s scientific credibility and client value proposition.
  </li>
  <li>
   Collaborate with cross-functional teams (Analytical, QA/QC, and Regulatory) to support integrated drug development solutions.
  </li>
 </ul>
 <p>
  <strong>
   2. Operational Responsibilities
  </strong>
 </p>
 <ul>
  <li>
   Perform route scouting and literature searches, and develop robust and scalable chemical processes using QbD principles.
  </li>
  <li>
   Conduct laboratory experiments for reaction optimization, impurity profiling, and process safety assessment.
  </li>
  <li>
   Prepare and review technical reports, SOPs, and technology transfer documents.
  </li>
  <li>
   Ensure compliance with GMP/GLP and EHS standards during lab-scale and pilot-scale operations.
  </li>
  <li>
   Participate in troubleshooting during scale-up or commercial production batches and provide technical support during client audits.
  </li>
 </ul>
 <p>
  <strong>
   3. Financial Responsibilities
  </strong>
 </p>
 <ul>
  <li>
   Optimize process economics by reducing cycle time, yield improvement, and minimizing raw material costs.
  </li>
  <li>
   Support cost estimation activities during project proposals or client RFQs by providing technical insights.
  </li>
 </ul>
 <p>
  <strong>
   4. People &amp; Collaboration Responsibilities
  </strong>
 </p>
 <ul>
  <li>
   Guide junior team members on experimental planning, data interpretation, and documentation best practices.
  </li>
  <li>
   Promote a culture of safety, learning, and innovation within the team.
  </li>
  <li>
   Work closely with program management and business development to align project goals with customer expectations.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Qualifications &amp; Experience
  </strong>
 </p>
 <ul>
  <li>
   M.Sc. (Organic Chemistry) / PhD
  </li>
  <li>
   3&ndash;7 years of experience in Process R&amp;D, preferably in CDMO organizations
  </li>
  <li>
   Hands-on expertise in synthesis, scale-up, impurity profiling, and technology transfer
  </li>
  <li>
   Familiarity with analytical techniques (HPLC, GC, NMR) and regulatory documentation
  </li>
 </ul>
 <p>
 </p>
</div>


Research Scientist

Validation & Engineering Group

<div><p><b><i>Validation &amp; Engineering Group, Inc. </i></b>(V&amp;EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.</p>
<p>We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:</p>
<ul><li><b>Process Development Sr Associate Scientist</b></li>
</ul>
<p>Qualifications:</p>
<p>Doctorate OR, Master+ 2 years of Scientific experience OR, Bachelors + 4 years of Scientific experience</p>
<p><b>Personnel with experience in the inspection (manual/automatic), packaging area, incoming (primary containers), forensic or QC (defects).</b></p>
<ul><li>Willing to work in a Process Development laboratory environment</li>
<li>Monitors field of expertise, including literature and technology development, and communicates relevant observations.</li>
<li>Understands and interprets primary components specifications and methods.</li>
<li>Demonstrates knowledge regarding metal, glass and polymer formation process and primary container components defects and classifications.</li>
<li>Performs Primary Packaging Evaluations and Glass/Polymers Forensic Analysis.</li>
<li>Introduces advanced scientific methods.</li>
<li>Develops and implements new and novel protocols to address specific issues.</li>
<li>Represent the department on project teams under supervision.</li>
<li>Initiates productive collaborations within and outside of the Process Development Department.</li>
<li>Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.</li>
<li>Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.</li>
<li>Participates with the external scientific community.</li>
<li>Assumes lead role in department-wide support efforts such as safety, OE and other committees. Develops and follows timelines for completing project teamwork.</li></ul></div>

ZL01-051525 Process Development Sr Associate Scientist

PI Industries Ltd.

<div><div><div><div><div><h2 class="jobSectionHeader"><b>Position Description</b></h2>
</div><div><div>
<div><div><div><div><b>Business Division: CSM AgChem</b></div></div><div></div><div><br>
<div><b>
Department: Technical Services</b></div></div><div></div><div><br>
<div><b>
Location: Jambusar</b></div></div></div><div></div><div><br>
<div>
<div><b>Position Title:</b><b> Scientist - Life Cycle Management</b></div></div><div></div><div><br>
<div><b>
Level: Executive Level</b></div></div><div><br>
<div><b>
Reporting To</b>:<b> Lead - Life Cycle Management</b></div>
</div>
</div><br>
</div></div></div></div><div><div><h2 class="jobSectionHeader"><b>Position Purpose</b></h2>
</div><div><div>
Scientists - Life Cycle Management are responsible for managing and improving targeted Yield &amp; Quality and upgrading processes to reduce wastes, solvents and utilities consumption, trouble shoot process problems efficiently to ensure targeted productivity and timely delivery of products.</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Strategic Responsibilities</b></h2>
</div><div><div>
Help achieve entire STRIVE initiatives (2.5 % of COGS)</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Operational Responsibilities</b></h2>
</div><div><div>
1. Planning &amp; execution of experiments w.r.t., the STRIVE action points for continual improvements of existing processes - for higher Yields, better quality, higher productivity, Recycling of solvents, reducing effluents and improved EHS performance. 2. Demo to Technology Transfer / Technical Services Team / Operation Team. 3. Provide support at time of implementation of STRIVE action points at Commercial scale. 4. Help in trouble shooting of the processes problems at commercial stages. 5. Participate in Route Cause Analysis of process problems. 6. Stress / Deviation / MOC studies for successful implementation of the STRIVE action points. 7. Observation of critical operating parameters and recording in the lab/Electronic note book. 8. Process write-up/ TOP/SOP/BFD preparations. 9. Binding of experimental analytical data sheets and submission of lab documents to library. 10. Performance tests of raw materials and its report submission. 11. Review and update of quality plan. 12. Literature search and its compilation. 13. Preparation of daily report / Man-hours utilization / Fume Hood Occupancy. 14. Use relevant MSDS for safe handling and disposals of chemicals/intermediates/final. 15. Coordination with QC for analytical support. 16. Raw materials planning. 17. Proper housekeeping and use of PPE&rsquo;s. 18. To ensure proper maintenance of lab equipment&rsquo;s.</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Financial Responsibilities</b></h2>
</div></div><div></div><div><div><h2 class="jobSectionHeader"><b>People Responsibilities</b></h2>
</div><div><ul><li>Actively participate to encourage the initiatives in conjunction with the Middle Management Team for better performance of the team.</li>
<li>Training need identification and coordinating with the middle management team for upgrading to the requisite skills.</li>
<li>Inspire &amp; motivate employees through demonstrated commitment to PI&rsquo;s values, vision &amp; mission and active participation in various team engagement activities</li>
</ul></div></div><div><div><h2 class="jobSectionHeader"><b>Education Qualification</b></h2>
</div><div><div>
MSc/PhD in Organic Chemistry</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Work Experience</b></h2>
</div><div><div>
5 - 8 Years Experience in R&amp;D and process development of Agrochemicals, Fine chemicals and their intermediates</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Industry to be Hired from</b></h2>
</div><div><div>
Agro-Fine-Chemicals</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Functional Competencies</b></h2>
</div><ul><li>Experience in managing R&amp;D or process development
</li><li>Strong technical knowledge to provide guidance to team members/juniors
</li><li>Understands the broader business drivers with ability to work collaborately with key functions areas such as R&amp;D, Production, QC/QA and EHS
</li></ul></div><div><div><h2 class="jobSectionHeader"><b>Interaction Complexity and Team Work</b></h2>
</div><div><div>
<div><div><div><div><b>Interaction<br>
</b></div></div><div><div><b>Frequency</b></div></div><div><br>
<div><b>
Purpose of Interaction</b></div></div></div><div><br>
<div>
<div><b>Internal:</b></div>
<div>
Head Technical Services</div>
<div>
Sr. GM / GM / DGM-TS/ Lead LCM</div></div><div></div><div><br>
<div>
As required for the business</div></div><div><br>
<div>
Strive objectives, Process trouble shooting, Improvement projects, new technology</div></div></div><div><br>
<div>
<div><b>External:
</b></div><div>Site head, EHS head, R&amp;D head, QA/QC head</div></div><div><br>
<div>
As required for the business</div></div><div><br>
<div>
Discuss business requirements, resolve queries and escalations</div></div></div></div></div></div></div></div></div></div>

Scientist - LCM

Sandoz India Pvt Ltd

<div>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 <strong>
  Your Key Responsibilities:
  <br/>
  <br/>
 </strong>
 <strong>
  Your Responsibilities Include, But Not Limited To
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Independently plan, organize, perform and document scientific experiments /GMP testing /manufacturing plant activities under minimal supervision; handle several activities at a time
  </li>
  <li>
   -Take over responsibility for and utilize special tools /equipment or specialized facilities as an expert; schedule and perform maintenance and qualification of instruments / equipment -Proactively identify conflict situations and contribute to solutions
  </li>
  <li>
   -Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security; lead initiatives to ensure continuous improvement. Documentation of raw data, evaluate and interpret results; propose and actively support the design of next experiments.
  </li>
  <li>
   Review and verify raw data generated by others; approval of tests / experiments performed by others. Write protocols, scientific reports or lab procedures based on templates or SOPs under minimal supervision. For technical development units: Develop new methods or optimize existing methods/processes (lab or plant); contribute to development and implementation of new technologies
  </li>
  <li>
   -For GMP units: ensure compliance to cGMP -For technology-focused roles: Perform information and literature searches under minimal guidance. Actively foster knowledge exchange.
  </li>
  <li>
   Train and coach associate scientists, technicians, temporary employees and employees under training / education -For project-focused role: Participate in function-specific sub teams and fulfill assigned project tasks and responsibilities under supervision -Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
  </li>
  <li>
   Contributes to some cost center goals and objectives -Design, plan and perform / supervise scientific experiments and contribute to project related scientific /technical activities under minimal supervision (e.g., interpret and report results, generate and evaluate data, draw relevant conclusions, optimize existing methods / processes).
  </li>
  <li>
   Establish innovative solutions for verification and control of critical quality attributes, critical material attributes or critical process parameter in cooperation with other colleagues. Establish control procedures and specifications and review test procedures. Generate scientific documents to hand over to internal and / or external partners (e.g., MST, TechOps, authorities, external companies) and support generation of international registration documents under minimal supervision.
  </li>
  <li>
   If assigned this task, maintenance of infrastructure / equipment and required investments (e.g. system ownership) -Generate lab procedures or SOP&rsquo;s, generate protocols and reports -Lead technical meetings during product development at the local level as well as on the level of SDC network -Report and present scientific /technical results internally and contribute to publications, presentations and patents.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Essential Requirements
  <br/>
  <br/>
 </strong>
 What you&rsquo;ll bring to the role:
 <br/>
 <br/>
 <ul>
  <li>
   M Pharm with 2-5 years' experience or PhD with 1-3 years' experience
  </li>
  <li>
   Functional Breadth.
  </li>
  <li>
   Operations Management and Execution.
  </li>
  <li>
   Collaborating across boundaries.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Environment.
  </li>
  <li>
   Experiments Design.
  </li>
  <li>
   Health And Safety (Ehs).
  </li>
  <li>
   Laboratory Equipment.
  </li>
  <li>
   Manufacturing Process.
  </li>
  <li>
   Materials Science.
  </li>
  <li>
   Process Simulation.
  </li>
  <li>
   Project Management.
  </li>
  <li>
   Sop (Standard Operating Procedure).
  </li>
  <li>
   Technical Writing.
   <br/>
   <br/>
  </li>
 </ul>
 Why Sandoz?
 <br/>
 <br/>
 Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
 <br/>
 <br/>
 With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
 <br/>
 <br/>
 Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!
 <br/>
 <br/>
 Join us!
</div>


Scientist - Pharmaceutical Development

Thermo Fisher Scientific

<div><p><b>Work Schedule</b></p>
Standard (Mon-Fri)<p></p><p><b>
Environmental Conditions</b></p>
Laboratory Setting, Office<p></p><p><b>
Job Description</b></p><p></p><p>
Do you have a passion for innovative ideas and groundbreaking discoveries? With over $1 billion invested annually in R&amp;D, at Thermo Fisher Scientific you&rsquo;ll help solve some of the world&rsquo;s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics. We empower our teams to put science into meaningful action and give our R&amp;D colleagues the autonomy, resources and tools they need to take science a step beyond.</p><p></p><p><b>
Location/Division Specific Information</b></p><p>
How will you make an impact?</p><p>
Responsible for conducting daily analyses and experiments to support biopharmaceutical process development. You will work within an interdisciplinary team of scientists where you will learn and apply your skills and ideas to projects.</p><p>
What will you do?</p><ul><li>
Perform laboratory experiments and routine analysis using size exclusion, ion exchange and reversed phase chromatography.</li><li>
Maintain laboratory, supplies, equipment, and data in accordance with site SOPs and policies.</li><li>
Responsible for performing in-depth analysis of analytical data and collaborate within the broader analytical team.</li></ul><p></p><p><b>
Who we are looking for: experience, skills &amp; abilities</b></p><ul><li>
Knowledge and expertise in performing analytical scale liquid chromatography on one or more of the following systems: ThermoFisher Vanquish, Core or Flex UHPLC, Waters Acquity or Agilent systems.</li><li>
Experience processing and reviewing data in Empower 3.</li><li>
Technical experience with the following assay techniques: Reversed Phase, Size Exclusion, Protein A Affinity, Ion Exchange and/or Hydrophobic Interaction Chromatography.</li><li>
Understand ICH method validation guidelines to assess method performance.</li><li>
Ability to work independently with excellent communication and prioritization skills.</li></ul><p></p><p><b>
Education</b> Bachelor in Molecular Biology / Chemistry / Biochemistry / Chemical Engineering, or a related field.</p><p><b>
Experience</b> Up to 2 years of experience related to the job description.</p><p><b>
Knowledge, Skills, Abilities</b></p><ul><li>
Passion for learning the analytical methods required for successful process development!</li><li>
High attention to detail.</li><li>
Strong desire to learning new skills.</li></ul></div><p></p>

Scientist I, Analytical Development

Merck

<div><p><b>Job Description</b></p><p></p><p>
We are seeking a strategic and technical team player with expertise in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing support. BDSC supports stage 1 &amp; 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities, process characterization, control strategy development, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, second generation process development and authoring of regulatory submissions.</p><p></p><p>
Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule biologics program activities. The individual will be responsible to support development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing biologics. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring</p><p>
In this role, the successful candidate will be responsible to</p><ul><li><p>
Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.</p></li><li><p>
Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.</p></li><li><p>
Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.</p></li><li><p>
Solves technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.</p></li><li><p>
Provides timely and accurate information and status updates to project sponsors and management.</p></li><li><p>
Champion compliance and safety; promote a culture of diversity, inclusion, and equity.</p></li></ul><p></p><p><b>
Minimum Education Requirement and Experience:</b></p><ul><li><p>
Bachelor&rsquo;s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with six (6) years of relevant industry experience</p></li></ul><p>
OR</p><ul><li><p>
Master&rsquo;s degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with four (4) years of of relevant industry experience</p></li></ul><p>
OR</p><ul><li><p>
Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with a no minimum relevant knowledge</p></li></ul><p></p><p><b>
Required Experience and Skills:</b></p><ul><li><p>
Strong fundamental knowledge in mammalian cell culture processing of biologics (large molecule products), recent advances, and challenges in the field</p></li><li><p>
Expertise in planning, execution, analysis, and documentation of all stages of cell culture process commercialization.</p></li><li><p>
Experience with late-stage commercial process development (CPD), technology transfer (TT), scale-down model qualification (SDMQ) and process characterization (PC).</p></li><li><p>
Experience authoring technical documentation in support of the following: process characterization (PC), process performance qualification (PPQ), risk assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.).</p></li><li><p>
Adaptability and agility to prioritize and deliver complex objectives, often on tight timelines, in a rapidly changing environment.</p></li><li><p>
Experience and aptitude to work and collaborate in internal and external cross-functional, matrixed teams.</p></li><li><p>
Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.</p></li><li><p>
Excellent interpersonal and communication skills</p></li></ul><p></p><p><b>
Preferred Experience and Skills:</b></p><ul><li><p>
Experience in CMC development teams.</p></li><li><p>
Experience with cell culture process development for biologics.</p></li><li><p>
Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control</p></li><li><p>
Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.</p></li><li><p>
Background in data science approaches related to cell culture and predictive modeling e.g., (metabolic flux (MFA) analysis, omics, machine learning; experience integrating PAT efforts)</p></li><li><p>
Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.</p></li><li><p>
Experience with mathematical modeling, theoretical scaling calculations, drug substance comparability, scale down establishment, computational fluid dynamics (CFD) modeling, Quality by Design (QbD) and Lean Six Sigma principles.</p></li><li><p>
Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).</p></li><li><p>
Demonstrated commitment and experience to coach and mentor staff to maximize talent development and utilization.</p></li></ul><p></p><p><b>
Required Skills:
</b></p>Biological Engineering, Bioreactors, Cell Cultures, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Computational Fluid Dynamics (CFD), Design of Experiments (DOE), Flux Analysis, GMP Compliance, Mammalian Cell Culture, Process Design, Process Optimization, Process Scale Up, Process Verification, Production Process Development, Small Molecule Synthesis, Technical Writing Documentation, Technology Transfer<p></p><p><b>
Preferred Skills:</b></p><p></p><p><b><br>
US and Puerto Rico Residents Only:</b></p><p></p><p>
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.</p><p>
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:</p><p></p><p>
EEOC Know Your Rights</p><p>
EEOC GINA Supplement
</p><p></p><p>We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another&rsquo;s thinking and approach problems collectively.</p><p></p><p>
Learn more about your rights, including under California, Colorado and other US State Acts</p><p></p><p><b>
U.S. Hybrid Work Model</b></p><p></p><p>
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as &ldquo;remote&rdquo;.</p><p></p><p>
The salary range for this role is</p>
$114,700.00 - $180,500.00<p></p><p>
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee&rsquo;s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.</p><p></p><p>
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.</p><p></p><p>
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.</p><p></p><p>
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.</p><p></p><p><b>
San Francisco Residents Only:</b> We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance</p><p></p><p><b>
Los Angeles Residents Only:</b> We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles&rsquo; Fair Chance Initiative for Hiring Ordinance</p><p></p><p><b>
Search Firm Representatives Please Read Carefully</b><br>
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</p><p></p><p><b>
Employee Status:
</b></p>Regular<p></p><p><b>
Relocation:</b></p>
Domestic<p></p><p><b>
VISA Sponsorship:</b></p>
No<p></p><p><b>
Travel Requirements:</b></p>
10%<p></p><p><b>
Flexible Work Arrangements:</b></p>
Not Applicable<p></p><p><b>
Shift:</b></p>
1st - Day<p></p><p><b>
Valid Driving License:</b></p>
No<p></p><p><b>
Hazardous Material(s):</b></p>
n/a<p></p><p><b>
Job Posting End Date:</b></p>
11/26/2025<ul><li><b>A job posting is effective until 11:59:59PM on the day </b><b>BEFORE</b><b> the listed job posting end date. Please ensure you apply to a job posting no later than the day </b><b>BEFORE</b><b> the job posting end date.<br>
</b></li></ul><br>
<p><b>Requisition ID:</b>R374276</p></div>

Senior Scientist, Engineering

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