Job Description

　　Our team is seeking an exceptional leader who is passionate about leading 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 Senior 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 to the FIH studies and commercial launch. The candidate will be a member of the BPD Leadership Team and directly responsible for a team of approximately 20-25 scientists and a portfolio of approximately 5-10 programs at various stages of development. The key accountabilities include effective management and development of the teams and individuals, strong leadership of CMC teams, championing the efforts for strategic progression of pipeline projects and technology development initiatives, managing cross-functional interactions with other teams within BPR&D, driving maturation of technological innovation for implementation into development workflows and/or GMP manufacturing settings, and strategic partnerships with Analytical, Drug Product, Clinical Manufacturing, Quality and Commercial Manufacturing groups. The candidate is also expected to participate in external technical and regulatory forums to bring the evolving knowledge to our company and influence regulatory landscape related to the manufacturing and launch of biologics. The candidate, working alongside key partners, is also expected to influence the digital strategy related to data management and data analyses approaches for BPD organization.

　　The successful candidate is expected to lead in a fast-paced, multidisciplinary, and highly matrixed team environment. The candidate is expected to have strong background in mammalian cell culture or purification process development or both, technical transfer of clinical and commercial processes, deep understanding of QbD framework including Critical Quality Attributes and Control Strategy, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising, and developing personnel in the team. The candidate will advance a culture of scientific excellence, compliance mindset, and collaboration with various partners and stakeholders. The successful candidate will be accountable for proactive resource planning and focus on talent development to build an integrated culture of innovation for BPD organization. The candidate will partner with leaders and senior staff in BPR&D and other groups in our company to enable effective pipeline decisions. Equally important, the candidate is expected to possess an innovative yet pragmatic mind-set, strong technical credentials, and a strong publication record.

　　Minimum required education:

　　Ph.D. in Biochemistry, Biologics Sciences, Chemical Engineering, or related field with 12+ years of relevant experience in the pharmaceutical industry, MS with 15+ years of relevant experience, or BS with 17+ years of relevant experience.

　　Required experience and skills:

　　Good technical knowledge of biotherapeutic process development (including in cell line, upstream, and downstream areas), manufacturing, analytical testing, and product characterization is required; ability to project achievable project plans to ensure effective and timely execution is essential.A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent. Demonstrated ability in leading cross-functional groups for effective CMC delivery is a must.Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, program risks and mitigation strategies. Strong knowledge and experience in bioprocess development, scale-up, technology transfer, and process characterization. In-depth knowledge in upstream cell culture process development or downstream protein purification development or both 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 INDs, IMPDs, and CTAs.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.Strong passion and commitment to integrate process science and innovation into biologic process development.Strong innovative mind-set demonstrated by technical accomplishments, external presentations, and a strong publication record.

　　NOTICEFORINTERNALAPPLICANTS

　　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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

　　Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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　　We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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　　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, generally Tuesday, Wednesday and either Monday or 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".

　　Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

　　Expected salary range:

　　$159,200.00 - $250,700.00

　　Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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　　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

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　　Requisition ID:R265865