Principal Scientist, Downstream Vaccine Process Development and Commercialization Job

Principal Scientist, Downstream Vaccine Process Development and Commercialization-PRO015109

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


The Vaccine Process Development and Commercialization (V-PDC) group within the Merck Manufacturing Division (MMD) focuses on late stage development and in-line support of vaccine products. We seek an energetic, people-oriented scientific leader with strong large molecule purification & downstream processing subject matter expertise and technical skills to lead process development and commercialization activities of multiple vaccine programs. Responsibilities also include scientific mentorship and technical develop of downstream bioprocess scientists and engineers. As a large molecule purification expert, you will:

1) Oversee and lead technical teams in developing and executing vaccine purification and other bioprocesses related to pipeline commercialization, life cycle management of the existing vaccine portfolio, and deviation investigations.

2) Interface closely with process, formulation, analytical, manufacturing, quality, and regulatory groups to develop and execute on long-term strategies and product trajectories.

3) Be the primary point of contact in managing relationships with senior leadership, outsourced organizations, and health authorities.

4) As a critical aspect of this role, you will teach, mentor, coach, and provide technical guidance.

You will focus on expanding and evolving our culture of continuous learning and improvement through collaborations with manufacturing and research organizations.

Qualifications

Education:

- B.S. in Chemical Engineering, Biochemical Engineering Bioengineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 15 years of relevant experience; or Master's degree with 12 years of relevant experience; or Ph.D. with 8 years of relevant experience.
Required:

- Expert in large molecule process development, or relevant, experience including scaling (up and down) and tech transfer of downstream large molecule drug substance downstream processes (lysis, normal and tangential-flow filtration, chromatography, continuous centrifugation, precipitation, and conjugation chemistry).

- Recognized SME with deep technical knowledge and in-depth experience with downstream process development & commercialization with ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development.

- Extensive experience in various lab scale process models from high throughput to small scale, manufacturing representative models.

- Ability to drive programs and experiments in the context of long-term commercialization plan.

- Experience with Quality by Design (QbD), Design of Experiments (DOE), and Lean Six Sigma principles.

- Advanced computer skills using statistical packages (JMP, MiniTab, etc) and operation of other peripheral devices.

- Subject matter expert in due diligence activities.

Preferred:

- Large molecule downstream process development expertise with multiple vaccine or biologics platforms including: recombinant protein, live viral, polysaccharide, and conjugate

- Knowledgeable in Drug Substance, end-to-end process development.

- Strong track record of effective collaboration across internal manufacturing and research divisions and with external academic and/or government research institutions.

- Recognized internationally as subject matter expert in large molecule drug substance purification (history of peer-reviewed publications and as invited speaker on these topics).

- Strong understanding of regulatory filing requirements (IND, MAA, BLA) with multiple agencies (FDA, EMA, JNDA, TGA).

- Prior experience with process transfer to internal and external manufacturing partners

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Process Engineering

Job Title:Prin. Scientist, Engineering

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 25 % of the Time

Number of Openings: 1

Shift (if applicable): 1st

Hazardous Materials: Potential to work with BSL2 compunds, live virus vaccines, general laboratory chemicals

Company Trade Name:Merck