Job Description General/Position summary:
This role provides technical microbiology leadership for QC environmental monitoring and utilities monitoring (EM/UM) laboratory supporting oral dose and cell therapy GMP manufacturing facilities. This person is responsible for hands-on management of the Micro ID lab and media growth promotion program while ensuring activities occur in an efficient and cGMP compliant manner fostering the Vertex vision and values. Key Duties & Responsibilities:
Required Education Level:
- Oversee the Micro ID laboratory operations of EM/UM lab to support manufacturing facilities.
- Subject matter expert for performing Microbial ID analysis
- Manage the media growth promotion program
- Serve as QC representative in cross-functional, cross-departmental working teams providing microbiological technical expertise
- Prioritize work appropriately to meet commitments on-time
- Leads compliance and efficiency related teams working towards the goal of continuous improvement to increase value and efficiency.
- Authors, reviews, and/or approve data, SOPs, methods, protocols and reports.
- May be required to lead and/or participate in OOS/OOT investigations and laboratory deviations. Identifies corrective actions to prevent reoccurrence
- A minimum of a Bachelor Degree in science or related discipline is required.
- 8 years of experience in pharmaceutical/biopharmaceutical industry with a minimum of 3 years of experience overseeing/performing Microbial ID program.
- Proficient in microbiological methodologies such as aseptic techniques, microbial ID, bioburden and endotoxin
- Experience with qualification and use of MALDI-TOF and MicroSeq instruments for performing Microbial ID
- Strong knowledge of US and EU cGMP regulations/guidance and experience with regulatory agency inspections.
- Effective communication skills, both verbal and written.
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com. This employer is a corporate member of myGwork, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.