Job Description
As part of Our Company's Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.
Under the general scientific and administrative direction of Director in the CCFS group and working in conjunction with internal and external partners, this individual will support late stage and commercial large molecule program activities within CCFS. The individual will be responsible for leading a team to support development activities, commercialization activities of late-stage pipeline and/ or post-market commercial manufacturing vaccines and biologics. For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring.
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In this role, the successful candidate will be responsible to:
- Coordinate project planning, resourcing, progress reporting, troubleshooting and people management.
- Serve 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.
- Responsible for process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful PPQs and BLAs for the company's pipeline.
- Manage large multifaceted projects as the leader of a cross-functional team.
- 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 non-technical 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 Requirement and Experience:
- Bachelor's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with ten (10) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry OR
- Master's degree in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with eight (8) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry OR
- Ph.D. in Chemical Engineering, Bioengineering, Biological Engineering, or a related field with five (5) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry
Required Experience and Skills:
- 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.
- Experience in leadership of CMC development teams.
- Experience authoring technical documentation in support of the following: process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions.
- 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 cross-functional, matrixed teams.
- Action-oriented, mindset for creativity; ability to take initiative, innovate, iterate, and problem-solve.
- Demonstrated commitment and experience to coach and mentor staff to maximize talent development and utilization.
- Excellent interpersonal and communication skills
Preferred Experience and Skills
- Over twelve (12) years of technical expertise in cell culture and fermentation sciences, leadership and project management, and regulatory knowledge in the Pharmaceutical/Biotech industry preferred.
- Experience with cell culture process development for both biologics and vaccines.
- Experience with high throughput microbioreactor systems, and advanced in situ analytics for process monitoring and control.
- Experience with state-of-the-art cell culture processes including intensified inoculum/fed-batch 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 on-the-floor 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.
- Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).
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, 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 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 candidate's relevant skills, experience, and education.
Expected US salary range:
$164,800.00 - $259,400.00
Available 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 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:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
11/15/2024
*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:R319718