Director, Biologics Process Development (BPD)

Job Description

Our team in Rahway, New Jersey, is seeking an experienced leader who will manage a team of scientists to support drug substance process development activities to enable and accelerate early and late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director, Biologics Process Development (BPD) within the Biologics Process Research and Development (BPR&D) organization is responsible for designing and implementing novel bioprocess technology platforms and processes for upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The candidate will be a member of the BPD Leadership Team and directly responsible for a team of approximately 10-15 scientists and a portfolio of approximately 3-6 programs at various stages of development. The key accountabilities include managing the work and personal development of direct reports while effectively interacting with other teams within BPD and staff in Process Cell Science, US Operations, Clinical Manufacturing, and Commercial Manufacturing groups. The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in managing work with external partners for timely execution of work.

The successful candidate is expected to collaborate in a fast-paced, multidisciplinary, and highly matrixed team environment. The candidate is expected to be experienced in mammalian cell culture or purification process development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising, and developing personnel under her/his/their supervision. The leader will maintain a strong network internally and will advance a culture of scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings. The successful candidate will serve as a sounding board for facilitating decision making, will be skillful in managing people, and will be accountable for talent development of individuals in her/his/their direct team. Finally, the candidate is expected to possess an innovative mind-set and proven technical credentials through external presentations and publications.

Minimum required education:

Ph.D. in Biochemistry, Biologics Sciences, Chemical Engineering, or related field with 10+ years of relevant experience in the pharmaceutical industry; MS with 13+ years of relevant experience; BS with 15+ years of relevant experience.

Required experience and skills:

• Experience in and good technical knowledge of biotherapeutic process development (including in cell line, upstream or downstream areas) or manufacturing is required; ability to project achievable project plans to ensure effective and timely execution is essential.
  
• Demonstrated ability in leading individuals with proven talent development skills.
  
• Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, program risks and mitigation strategies. In-depth knowledge in upstream cell culture process development or/and downstream protein purification development to support development of pipeline projects, platforms, and innovative technologies.
  
• Proven track record of authoring and providing critical input to the regulatory submissions including but not limited to Investigational New Drugs, Investigational Medicinal Product Dossier s, and Clinical Trial Application s.
  
• Ability to work closely with cross-functional stakeholders to ensure the team alignment with functional objectives.
  
• Ability to communicate program progress, issues, and mitigation plans to the senior management.
  
• Innovative mind-set demonstrated by technical accomplishments, external presentations, and publications.
  

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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
$169,700.00 - $267,200.00

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 .

You can apply for this role through (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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:
Account Management, Account Management, Adaptability, Bioproducts, Cell Culture Process Development, Cell Cultures, Chemical Engineering, Chemical Technology, Confidentiality, Cross-Functional Teamwork, Data Entry, Experimentation, Good Laboratory Practices (GLPs), Innovation, Mammalian Cell, Mammalian Cell Culture, Mentoring Staff, Negotiation, People Leadership, Pharmaceutical Management, Pharmaceutical Process Development, Process Scale Up, Program Risk Management, Project Planning, Protein Characterization {+ 2 more}

-Preferred Skills:

Job Posting End Date:
08/16/2025
*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: R356032