Senior Process Development Scientist - Bioconjugation & Commercialization

Job Description

As part of Our Company’s Manufacturing Division, within the Vaccine Drug Substance Commercialization (VDSC), the Bioconjugation and Chemistry (BCC) team provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for biologically derived drug substances (e.g., therapeutic proteins, antibody drug conjugates, or vaccines) generated from bioconjugation processes.

For late-stage pipeline commercialization, activities include process characterization, technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions. 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.

This role may require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing. This role may also require approximately 25% of time spent on domestic (e.g. to Rahway, NJ site) or international travel.

In this role, the successful candidate will be responsible for:

• Technical leadership on design, planning, and executing laboratory experiments and investigations for the purposes of mechanistic understanding and to enable process development, problem solving, and to reduce risk inherent in scale up or scale down of drug substance / bioconjugation processes.

• Responsible for planning or executing scale studies to support commercial process validation, process characterization, and investigation evaluations, including studies performed either in-house or externally.

• Design, plan, and execute laboratory experiments to generate high quality data. Perform data analysis and ensure results are reported clearly and accurately and effectively communicate study results to stakeholders via presentations and technical reports.

• Authors experimental protocols and documents work in a lab notebook.

• Documents lab activities, findings and conclusions in scientific reports, and presents knowledge at appropriate forums. Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations.

• May be responsible for managing multifaceted projects as the leader of a cross-functional team. As an individual contributor, may be concerned with clearly identifiable elements or functions within a larger project team.

Education & Experience:

• Bachelor's Degree in Engineering, Science, or related field with a minimum of four (4) years of large molecule/anti-body drug conjugate and/or commercialization experience; OR

• Master's Degree with a minimum of three (3) years of large molecule/anti-body conjugate experience; OR

• Doctoral Degree (Ph.D.) with no (0) years of experience.

Required Skills and Experience:

• Experience with large molecule manufacturing processes including on-the-floor GMP manufacturing support

• Experience designing process development experiments using risk-based methodology or similar

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

• Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions such as BLAs, INDs, or other regulatory source documentation

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

• Possesses outstanding communication skills

• Ability to coach others and manage small teams effectively

Preferred Skills and Experience:

• Experience with bioconjugation or antibody drug conjugate processes

• Experience interacting with and overseeing commercialization activities at both internal and external manufacturing sites

• Experience with process scale-up and/or technology transfer, moving from laboratory to pilot plant or production scale or similar

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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:

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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’s thinking and approach problems collectively.

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U.S. Hybrid Work Model

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 “remote”.

The salary range for this role is

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: