Assoc. Dir., Bacterial Fermentation SME

Job title: Assoc. Dir., Bacterial Fermentation SME in West Point, PA at MSD
Company: MSD
Job description: Job DescriptionThe Polysaccharide Vaccine Technical Operations organization within our Company Divisions is responsible for supporting vaccine operations as the technical subject matter experts. Responsibilities of the organization include technical process support, project management / change control, deviation management, and continuous improvement.The Associate Principal Scientist role will be to provide in-house subject matter expertise for bacterial fermentation. The subject matter expert will be responsible for optimization of capsular polysaccharide productivity during culture biosynthesis, investigation support for atypical processing events during fermentation, and further characterization of the culture and purified capsular polysaccharides. The ideal candidate will have a strong background in microbiology and bacterial fermentation with natural product discovery experience a plus.Responsibilities Include but are not limited to:

• Provide microbiology / bacterial fermentation subject matter expertise support to the production departments that manufacture capsular polysaccharide-based vaccines.
• Project lead for the optimization of capsular polysaccharide production in bacterial fermentation cultures.
• Designs and leads execution of experimental protocols using lab facilities and/or production equipment at full scale to enhance bacterial fermentation process understanding.
• Communicating study designs and data driven results to all levels within and across organizations and incorporating stakeholder feedback.
• Provide microbiology support to operational investigations and problem-solving, including leading investigations and analyses to determine root cause and impact, recommending corrective actions, and seeing them through to successful, sustainable implementation.
• Providing microbiological leadership and support for a vaccine manufacturing facility, including data analysis, troubleshooting, problem solving, coaching/teaching, preparing, reviewing and approving relevant documentation for technical and regulatory compliance
• Hands-on leadership and participation in laboratory activities / production floor
• Examines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
• Authors and approves technical documentation to support manufacturing investigations and process enhancements.
• Collaborates and engages with counterparts within technical operations, site manufacturing, commercialization, our Research Division, and process support labs within our global network.
• Troubleshooting of suspected Microbiological Contamination incidents

Minimum Education Required and Experience:

• Bachelor of Science (BS) degree with eight (8) years working experience in bacterial fermentation or a related discipline in a pharmaceutical, biotech, or academic setting; OR
• Master of Science (MS) degree with six (6) years working experience in bacterial fermentation or a related discipline in a pharmaceutical, biotech, or academic setting; OR
• PhD with concentration in Biology, Microbiology or related science with three (3) years working experience in bacterial fermentation or a related discipline in a pharmaceutical, biotech, or academic setting.

Required Skills and Experience:

• Experimental Design
• Ability to collect and analyze data
• Expertise in a range of molecular and cellular characterization techniques
• Solid computer skills, independent experimental design and execution, and analytical problem-solving capabilities.
• Good verbal and written communication skills.
• Demonstrated initiative and innovative process-oriented thinking within a team environment.
• Ability to lead and coach others to solve problems.
• Strong problem-solving skills and a hands-on approach to problem solving
• Project management skills and experience
• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.

Preferred Skills and Experience:

• Experience in vaccine development or manufacturing
• Track record of publications
• Experience with natural product discovery and production
• Experience with bacterial fermentation optimization
• Experience with cultures which generate capsular polysaccharides
• Working in a cGMP environment
• Sterile, aseptic, or microbiological experience in a manufacturing environment
• Working knowledge of regulatory expectations of pure culture processing

Current Employees applyCurrent Contingent Workers applyUS 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 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 characteristics. As 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 another’s thinking and approach problems collectively.U.S. Hybrid Work ModelEffective 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”.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos 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 OrdinanceSearch 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: RegularRelocation: DomesticVISA Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: HybridShift: 1st - DayValid Driving License: NoHazardous Material(s): n/aRequired Skills: Adaptability, Adaptability, Automation Systems, Capital Project Management, Change Management, Clinical Manufacturing, Communication, Corrective Action Management, Data Analysis, Decision Making, Drug Product Manufacturing, Interpersonal Relationships, Lean Manufacturing, Management Process, Managing Change Requests, Manufacturing Scale-Up, Microbiological Cultures, Microbiology, Molecular Microbiology, Pharmacokinetics, Pharmacology, Product Commercialization, Project Management, Project Optimization, Regulatory Compliance {+ 5 more}Preferred Skills:Job Posting End Date: 06/12/2025*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.
Expected salary:
Location: West Point, PA
Apply for the job now! [ad_2] Apply for this job