Director, Microbiology

Job Description

Job Description:

Our company's Research Labs (our Research & Development Division) Microbiology Center of Excellence team (CoE Microbiology) is seeking a Director for the US CoE Microbiology group based in Rahway & WestPoint. The CoE Microbiology organization consists of four microbiology labs sites located in the US and Europe (Dunboyne in Ireland, WAG in Switzerland, WestPoint, and Rahway in the US) and serves all modalities (Vaccines, Small Molecules, Biologics) in the network. The primary objective of the Microbiology CoE team is to carry out clinical microbiological release of pipeline products, support clinical operations, develop new microbial detection technologies, execute microbiological studies, and serve as a knowledge center for Microbiology for the entire Research & Development Division network. The US CoE Director will provide guidance, lead activities, and strengthen a team of microbiologists whose roles include executing analytical methods to release clinical drug substance and drug product, supporting manufacturing, and implementing alternative microbial methods. This person will closely collaborate with the other Directors Microbiology in WAG & Dunboyne. This role contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable, which involves the development of robust chemical and biochemical processes, market formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality, Pharmaceutical Operations, and partners in commercialization and manufacturing in aspects of quality control, compliance, and strategic partnering.

Primary Responsibilities:

• Reports to the Executive Director of Analytical Research Division (ARD) CoE Microbiology.
• Leads an expanding team (~26 scientists) across Rahway and West Point PA sites.
• Works closely within multidisciplinary DSCS teams.
• Responsible for clinical release for various processes and dosage formulations.
• Guides future activities for Analytical R&D and DSCS based on regulatory and industry trends.
• Engages with the CoE Microbiology leadership team and extended leadership teams to advance departmental strategic and cultural initiatives.
• Identifies, recruits, onboards, and develops employees.
• Establishes a viable succession plan for key positions.
• Ensures cGMP compliance and operational excellence in the laboratories.
• Maintains a state of inspection readiness.
• Performs proactive resourcing planning and risk assessment strategies.
• Creates and maintains an effective network internally and across the regulatory community.
• Advances a culture of scientific excellence, GMP compliance mindset, and collaboration with various partners and stakeholders in other development departments.
• Can embed Diversity, Equity, Inclusion and empowerment of the team to the organization

Essential Knowledge & Skills:

• Pharmaceutical Microbiologist (Operations as well as Analytics).
• Strong people management skills.
• Demonstrated ability in leading teams and talent development.
• Project management skills.
• Ability to work in a team environment with cross-functional interactions.
• Excellent scientific communication, interpersonal, and collaborative skills.
• Strength in delivering results on firm deadlines.
• Experience representing the laboratory for internal and external audits.
• Leads microbiological investigations
• Review and approval of data and reports.
• SOP development.
• Quality System experience.
• Thorough working knowledge of GMPs, ICH, Pharmacopoeia, and relevant FDA guidelines.
• Desire and ability to learn new concepts outside of core expertise and training

Education Minimum Requirements:

• BS or MS in Microbiology/Molecular Biology or related science with at least 10 years of industrial experience leading a QC lab and working together with operations.
• Ph.D. in Microbiology/Molecular Biology or related science with 5 years of industrial experience leading a QC lab and working together with operations.

#AR&D

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.

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:

$164,800.00 - $259,400.00

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:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID:R282062