Job Description

We are seeking an exceptional scientific leader for the role of Distinguished Scientist (equal to the Executive Director level), in the Sterile Product Development department, located in Rahway, NJ.

Our new multi-modality drug product development and clinical manufacturing facility (FLEx) and new research laboratory (Biologic Development Center; BDC) has been built in Rahway, NJ in support of our company’s diverse and growing pipeline of oral and injectable therapeutics and vaccine drug products. The Sterile Product Capabilities lead will report to the Associate Vice President of Sterile Product Development, supporting the talent and infrastructure build plan for sterile therapeutic and vaccine R&D and manufacture in the new Rahway facilities, in addition to continued utilization of other facilities in the network. The role will require strategic leadership during the start-up phase of the FLEx manufacturing facility and BDC, including advising and executing on timely acquisition and qualification of sterile processing equipment, laboratory infrastructure, driving development of the training curriculum, and building the road-map towards achieving full utilization of the new and existing facilities without impact to program timelines. To ensure strong linkage between pipeline needs and ongoing GMP capability build, the incumbent will have a matrixed reporting relationship to FLEx leadership.

The key deliverable of this role is to help establish and maintain world-class sterile drug product research and clinical supply manufacturing capabilities. The incumbent will also be responsible for the invention and application of new tools in support of the our company’s sterile drug product pipeline from FIH to Phase 3 clinical supplies. In addition, the Sterile Product Capabilities leader is responsible for advancing a culture of scientific and operational excellence, identifying emerging trends in aseptic processing, automation and the regulatory landscape in the management of Sterile Drug Product research and manufacturing facilities.

In addition to the installation of capabilities, the incumbent will be responsible for providing tactical and strategic level guidance to the cross-functional teams working in the FLEx and BDC facilities with FLEx leadership. The incumbent will ensure that the pilot and laboratory facility-capabilities have line of sight to the commercial sterile drug product network and thoughtful strategies for the application of FLEx vs other internal and external assets to best support pipeline program development milestones. In addition, the incumbent will promote behavioral norms especially related to inclusion, diversity and enterprise leadership. Additional key deliverables include developing strategies to ensure right first time start-up of the sterile instance of FLEx, development of staff, identification and development of new technology required in support of advanced manufacturing, operational efficiency or product enhancement, and the creation of knowledge to support product design and commercialization of new products into our manufacturing division.

General Responsibilities include but are not limited to:

• Setting the strategic start-up plan for the sterile instance of FLEx, aligned to the Pharm Sciences and our company’s research laboratory strategies, and the long-range operating plan to achieve the FLEx vision

• Ensuring that the BDC capabilities continue to meet evolving pipeline needs

• Ensuring that existing sterile drug product laboratories and GMP facilities (e.g. Sterile Liquid Pilot Plant) are fully utilized and capable of supporting our company’s pipeline

• Being the voice of the pipeline on FLEx decisions as pertains to sterile manufacturing, so as to ensure speed to clinic, robust technology transfer to commercial sites, and best science at first filing

• Collaborating with peer leaders in Sterile Product Development, Process R&D, Analytical R&D, and our Manufacturing Division’s commercialization to connect pipeline needs to prioritized facility resources

• Member of site and Pharm Sciences leadership committees (eg. safety, quality, innovation)

• Serve as capital team or operational readiness leader as needed

• Setting up standard work that leads to efficiency and reproducibility in approach as benchmarked externally

• Setting milestones for sterile capability readiness and KPIs as measures of success

• Defining process development efforts required from FLEx in addition to clinical supply manufacturing.

Qualifications:

• Academic background

  • BS or MS degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or a related field with at least 15 years of sterile drug product (therapeutics and vaccines) development and manufacturing experience

  • Or, PhD in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or a related field with 10 years of sterile drug product (therapeutics and vaccines) development and manufacturing experience

• Critical Skills

  • Minimum of 10 years experience in developing and manufacturing sterile drug product formulation and process including small molecules and large molecules

  • Minimum of 10 years of proven experience with late stage development and filing of sterile therapeutics and vaccine drug products

  • Experience in developing lyophilized/liquid vials, syringe, cartridge, pediatric formulations, and novel drug product presentations

  • Strong communication and collaboration skills, with a diverse group of stakeholders

  • Strong problem-solving skills

  • Strength in delivering results on time

  • Demonstrated project management skills

  • Ability to integrate pharmaceutical development/CMC with Quality, Regulatory, Operations, Non-clinical, Clinical functions

  • Ability to work under pressure in face-paced environment

• Critical Behavioral and Leadership Competencies

  • Cross-functional collaboration, stakeholder management

  • Able to lead organizational change and champion a learning culture

  • Sound business decision making

  • Focus on delivering customer value

  • Proactive resource planning, project selection and prioritization, risk assessment strategies and budget management where necessary

  • Ability to communicate risks and develop contingency plans

• Personal Attributes and Characteristics

  • Demonstrated interest working in a diverse and constantly changing environment

  • Resilient and able to coach others to be resilient

  • Detail oriented and organized

  • Ability to inspire others in a team environment and promote a growth mindset

  • Demonstrated ability for critical thinking, problem solving, and innovation

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.

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.

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:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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, 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:

$200,200.00 - $315,100.00

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.

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:

Domestic/International

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a