Associate Principal Scientist, Cell Culture and Fermentation Sciences

Job Description

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

As part of Our Company’s Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.

Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and external partners, this person will support late stage and commercial large molecule program activities within CCFS and will be responsible to lead development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing vaccines and 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.

Position Responsibilities:

· Ensures project results meet requirements regarding technical quality, reliability, schedule, and cost.

· 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.

· Monitors performance and recommends schedule changes, cost adjustments or resource additions.

· Solves technical and non-technical problems throughout the life of the project, tries to resolve problems during the design and planning phases whenever possible.

· Provides timely and accurate information and status updates to project sponsors and management.

· May be responsible for managing large multifaceted projects as the leader of a cross-functional team.

Education Requirements:

· Ph.D., Master’s, or Bachelor’s in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with minimum 4 year (Ph.D.), 6 years (Masters), 8 years (Bachelors) of industry experience

Required Experience and Skills:

· Technical background and hands-on experience with mammalian cell culture and fed-batch processes to produce recombinant proteins

· Working knowledge of statistical methods (design of experiment, multivariate data analysis) and tools (SIMCA, JMP, etc.)

· Comprehension of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors and bioreactor scale-up principles from laboratory to large scale

· Ability to direct the planning, execution, analysis, and documentation of all stages of cell culture process development.

· Ability to work effectively in cross-functional and matrixed team environment; collaborate with both internal and external partners including vendors

· Demonstrated ability for taking initiative, creativity, and innovation in problem solving

· Experience with late-stage commercial process development, technology transfer, scale-down model qualification and process characterization.

· Outstanding communication and people skills. Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.

· Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions

· Proven track record of accomplishments in upstream process and technology development with a strong scientific publication and presentation track record.

Preferred Experience and Skills:

· Experience with cell culture process development for both biologics and vaccines.

· Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control

· Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch and perfusion process development.

· 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)

· Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support, familiarity with manufacturing batch record reviews and/or operations.

· 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.

· Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are ...

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & 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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R202545