Associate Principal Scientist, Downstream Vaccines and Advanced Biotechnologies Process R&D Full-time

Associate Principal Scientist – Downstream Vaccines and Advanced Biotechnologies Process R&D

Vaccines and Advanced Biotechnologies (VAX) Process R&D is responsible for the development and clinical manufacturing of Drug Substance (DS) and Drug Product Intermediates (DPI) for the vaccine and advanced therapy pipeline, spanning from preclinical to commercialization stages. We are part of the Process R&D organization, which enables modality-agnostic DS/DPI process development and clinical manufacturing for all of our company's pipeline. Our Discovery Interface team works closely with our Discovery organizations across Infectious Disease and Vaccines, Oncology, Neuroscience, and Immunology, and seeks to embed developability/manufacturability considerations into early research discussions in order to enable more seamless and rapid progression of candidates from Discovery into Process Development and Clinical Supply Manufacturing.

We are seeking an innovative, highly motivated, and experienced Associate Principal Scientist to join us at our research and development site in West Point, PA (outside Philadelphia). The candidate will be responsible for scientific/technical leadership of a downstream/bio-purification process development team, and will also be a critical member of cross-functional program/project teams. This will require frequent collaboration with cross-functional teams including colleagues in Discovery, Analytical, Formulation, and Enabling Technologies. The candidate should have a strong background in recombinant protein therapeutic/vaccine process design and understanding of various purification modalities, including but not limited to column chromatography (SEC, IEX, Affinity, MMC, HIC, etc.) and filtration unit operations (depth filtration, sterile filtration, viral filtration, TFF), as well as advanced knowledge in peptide/protein handling and purification techniques. Alternatively, the candidate will have a strong background in biomolecule conjugation techniques and conjugate modalities (e.g., conjugate vaccines, antibody-drug conjugates). Preferably, the candidate will have experience with both recombinant protein purification and conjugation process development.

Primary responsibilities include, but are not limited to:

• Lead early downstream process design and development for recombinant subunit and/or conjugate vaccine products.
• Contribute to the development of new principles, concepts, methods, and workflows to enable rapid early process development for new molecules emerging from Discovery.
• Design, execute, and analyze process development experiments to maximize understanding of recombinant subunit and/or conjugate vaccine production processes, thereby de-risking later stage process/product development.
• Represent functional area in cross-functional and strategic teams engaged in novel vaccine development.
• Serve as the scientific/technical mentor for junior staff. Provide technical guidance in the various aspects of downstream/bio-purification process development for vaccines and advanced biotechnologies.
• Support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development.
• Analysis of downstream/bio-purification experiments through basic analytical techniques including SDS-PAGE, UV-Vis, HPLC, Light Scattering.
• Data interpretation and presentation, manuscript/patent preparation.

Education Minimum Requirement:

• Must have a BS or MS or PhD in engineering or biological sciences.
• Engineering: Chemical Engineering, Bioengineering, Biomedical Engineering.
• Science and Technology: Cell Biology, Biological Sciences, Biotechnology.
• For BS candidates, at least seven (7) years of experience in a pharmaceutical or biotechnology-related position.
• For MS candidates, at least five (5) years of experience in a pharmaceutical or biotechnology-related position.
• For PhD candidates, at least three (3) years of experience in a pharmaceutical or biotechnology-related position.

Required Experience and Skills:

• Must have strong scientific and hands-on understanding of a wide variety of common downstream unit operations for large molecule purification (e.g., depth filtration, chromatography, tangential flow filtration), biotherapeutic and/or vaccine production, and purification process development and sound understanding of scale-up principles.
• At least 5 years of hands-on experience in the optimization of downstream processes.
• Some prior experience with statistical design of experiments (DOE) and/or algorithmic process optimization.
• Strong understanding of, or hands-on experience in, cGMP manufacturing.
• Ability to work effectively both independently and in a team-focused environment.
• Well-developed organizational, record-keeping, and timeline/resource-mapping skills.

Preferred Experience and Skills:

• Experience in purification unit operations using AKTA platform (or similar FPLC system)
• Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates)
• Demonstrated knowledge of peptide and protein biochemistry (e.g., structure, function, immunology), and cutting-edge methodologies related to protein isolation/purification
• Experience in mentoring others and leading small technical development teams
• Experience in authoring and reviewing CMC regulatory documentation
• Experience with process and technology transfer

The successful candidate will be expected to demonstrate the ability to communicate results of his/her work in both verbal and written formats. They are also expected to demonstrate flexibility in responding to changing priorities or dealing with unexpected events. In addition to the core responsibilities outlined above, the candidate will be expected to comply with all required training and maintain a focused attention on laboratory safety for him/herself and his/her team.

Position may require employee to be willing to work with infectious agents, pathogens, and/or potent compounds. Some travel may be required. This position may require occasional off-hour and weekend work.

Required Skills: Accountability, Animal Vaccination, Antibody Drug Conjugates (ADC), Biomedical Engineering, Biomedical Sciences, Biomedical Technologies, Cell Line Development, Column Chromatography, Detail-Oriented, Downstream Process Development, Drug Delivery Technology, Drug Development, Expression Vectors, Immunoassays, Innovation, Interpersonal Relationships, Laboratory Safety, Leading Project Teams, Machine Learning (ML), Mechatronics, Molecular Biology, Neurotrophins, Pharmaceutical Formulations, Pharmaceutical Process Development

Preferred Skills:

Experience in purification unit operations using AKTA platform (or similar FPLC system), Experience with biomolecule conjugation (e.g., conjugate vaccines, antibody-drug conjugates), Demonstrated knowledge of peptide and protein biochemistry (e.g., structure, function, immunology), and cutting-edge methodologies related to protein isolation/purification, Experience in mentoring others and leading small technical development teams, Experience in authoring and reviewing CMC regulatory documentation, Experience with process and technology transfer

The salary range for this role is $139,600.00 – $219,700.00. 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'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.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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.

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.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only: 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' Fair Chance Initiative for Hiring Ordinance.

Search Firm Representatives Please Read Carefully 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: Regular

Relocation: Not Applicable