Merck Jobs

Job Description

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 broadly experienced 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, will be a critical member of and/or leader of cross-functional program/project teams, and may also serve as the personnel manager of a small team. This role will require frequent collaboration with cross-functional teams including colleagues from Discovery, Analytical, Formulation, and Enabling Technologies. The candidate should have a strong background in recombinant protein therapeutic/vaccine 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 cutting edge 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. Experience with affinity chromatography and/or live virus purification is also preferred.

Primary responsibilities may include, but are not limited to:

• Guide overall downstream/purification process design strategy, across multiple programs spanning a range of molecule types (e.g., recombinant proteins, conjugates)

• Lead early stage downstream/purification process design and development for recombinant subunit and conjugate vaccine candidates (with future potential for inclusion of live virus/vector projects in scope).

• Manage a small team of scientists as both a technical team lead and personnel manager.

• 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, and as opportunities become available, serve as a cross-functional team lead

• Serve as the scientific/technical mentor for less experienced staff. Provide technical guidance in the various aspects of downstream/bio-purification process development for vaccines and advanced biotechnologies.

• Generate and support strategic initiatives and innovation in the areas of vaccine and advanced biotechnology process development.

• Setting up process-analytical workstreams for analysis of downstream/bio-purification experiments through basic analytical techniques including (but not limited to) SDS-PAGE / Western blotting, UV-Vis, HPLC, Light Scattering

• Interpretation and presentation of complex data sets (including use of statistical and modeling approaches), followed by manuscript/patent preparation and submission

Education Minimum Requirement:

• Must have a BS or MS or PhD in engineering or biological sciences

Required Experience and Skills:

• For BS candidates, at least fourteen (14) years of experience in a pharmaceutical or biotechnology-related position.

• For MS candidates, at least fourteen (14) years of experience in a pharmaceutical or biotechnology-related position.

• For PhD candidates, at least nine (9) years of experience in a pharmaceutical or biotechnology-related position.

• 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.

• At least 9 years of hands-on experience in the design/optimization of bioprocesses

• Significant prior experience with statistical design of experiments (DOE), algorithmic process optimization, and/or structural/biophysical model-guided approaches.

• 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.

• Strong contributions to the field of vaccine development and/or biomolecule purification via publications and/or patents

Preferred Experience and Skills:

• Experience as personnel manager for small groups of scientists/engineers

• 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

• Sound understanding of bioprocess scale-up principles

• Experience in mentoring others and leading technical development teams

• Experience with authoring and reviewing CMC regulatory documentation

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.

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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.

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

09/27/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 09/27/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R313450