Director, Engineering
Director, Engineering
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$ 169700 - 267200
1 Vacancy
Job Description
Job Description
We are seeking a strategic and technical leader with expertise in cell culture development & commercialization to lead a team of approximately 1015 scientists in Rahway NJ who lead multidisciplinary program teams and execute laboratory activities. The primary objective of the Biologics Drug Substance Commercialization (BDSC) Cell Culture Sciences department is to provide the technical leadership and laboratory capabilities in support of latestage pipeline commercialization and postmarket commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including various pipeline commercialization activities process characterization control strategy development technology transfer to internal and external manufacturing sites manufacturing investigations process validation second generation process development and authoring of regulatory submissions.
Under the general scientific and administrative direction of the Head of Biologics Cell Culture Sciences and working in conjunction with internal and external partners this individual will support late stage and commercial large molecule biologics program activities. The individual will be responsible for leading a team of scientists to support development activities commercialization activities of the latestage biologics pipeline and postmarket commercial manufacturing support for commercial biologic products.
This challenging position requires a clear vision for team development demonstrated leadership skills critical thinking abilities effective technical and communication skills deep cell culture subject matter expertise a strong understanding of drug commercialization and the regulatory landscape.
In this role the successful candidate will be responsible to
- Manage and mentor a team of scientists specializing in biologics commercialization serving as the scientific/technical mentor for junior staff.
- Provide technical guidance in the various aspects of Cell Culture process development/commercialization for large molecule products.
- Coordinate project planning resourcing progress reporting troubleshooting and people management.
- Provide technical oversight of process development process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the companys pipeline.
- Manage and/or mentor leaders of large multifaceted projects of crossfunctional teams.
- Ensures project results meet requirements regarding technical quality reliability schedule and cost.
- Monitors performance and recommends schedule changes cost adjustments or resource additions.
- Solves technical and nontechnical problems throughout the life of the project tries to resolve problems during the design and planning phases whenever possible.
- Provides timely and accurate information and status updates to project sponsors and management.
- Champion compliance and safety; promote a culture of diversity inclusion and equity.
Minimum Education Requirements and Experience:
- Bachelors degree in Chemical Engineering Bioengineering Biological Engineering or a related field with fourteen (14) years of combination of experience including team management technical expertise in cell culture and regulatory knowledge in the pharmaceutical industry. OR
- Masters degree in Chemical Engineering Bioengineering Biological Engineering or a related field with twelve (12) years of combination of experience including team management technical expertise in cell culture and regulatory knowledge in the pharmaceutical industry. OR
- Ph.D. in Chemical Engineering Bioengineering Biological Engineering or a related field with eight (8) years of combination of experience including team management technical expertise in cell culture and regulatory knowledge in the pharmaceutical industry.
Required Experience Skills and Competencies:
- Three or more (3) years experience managing a team of scientists; completing people management responsibilities including both performance and talent management activities
- Demonstrated ability in leading teams with proven talent development skillsets.
- Strong fundamental knowledge and subject matter expertise with mammalian cell culture processing of biologics (large molecule products) recent advances and challenges in the field
- Expertise in independently conducting and directing the planning execution analysis and documentation of all stages of cell culture process commercialization.
- Risk assessment control strategies process comparability reports Process performance qualification and/or regulatory submissions.
- Experience supporting/writing regulatory filings (IND MAA BLA) and supporting inspections with multiple agencies (FDA EMA JNDA TGA).
- Proven leadership and project management skills to drive initiatives and team performance.
- Adaptability and agility to prioritize and deliver complex objectives often on tight timelines in a rapidly changing environment.
- Experience and aptitude to lead work and collaborate in internal and external crossfunctional matrixed teams.
- Actionoriented mindset for creativity; ability to take initiative innovate iterate and problemsolve.
- Excellent interpersonal and communication skills
Preferred Experience and Skills
- Multiyear experience with cell culture process development for large biologics products.
- Experience with high throughput microbioreactor systems and advanced in situ analytics for process monitoring and control.
- Experience with stateoftheart cell culture processes including intensified inoculum/fedbatch and perfusion process development.
- Background in data science approaches related to cell culture and predictive modeling e.g. (metabolic flux (MFA) analysis omics machine learning; experience integrating PAT efforts)
- Experience with onthefloor Good Manufacturing Practice (GMP) manufacturing support familiarity with manufacturing batch record reviews and/or operations.
- Experience with mathematical modeling theoretical scaling calculations drug substance comparability scale down establishment computational fluid dynamics (CFD) modeling Quality by Design (QbD) and Lean Six Sigma principles.
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 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:
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 anothers 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 officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 candidates relevant skills experience and education.
Expected US salary range:
$169700.00 $267200.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
06/2/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
