Sr. Manager, Analytical Quality Control
Position Summary:
Work Schedule: Monday-Friday, core hours 8am-4:30pm
100% on-site (San Diego)
Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Catalent’s San Diego facility focuses on early-stage development of small molecule and peptide drug candidates from the bench to the clinic. This facility offers an array of services that support oral and injectable dosage forms that include preformulation testing, formulation and analytical development, cGMP manufacturing and clinical packaging, labeling, and worldwide distribution. Our San Diego location is the home of our Catalent Spray Drying technologies with downstream roller compaction capabilities to support the needs of our client’s most challenging compounds.
The Sr. Manager, Analytical Quality Control is responsible for maintaining an internal QC sub-group of chemists, which may include tiered management responsibilities as well as oversight of ancillary functions within the QC team. They must demonstrate flexibility, leadership and adaptability to the ever-changing demands of the department and maintain excellent communication with the QC department head as well as the heads of other departments.
The Role:
Direct supervision of QC chemists, including managerial responsibilities such as development plans, goal setting, and performance reviews.
Managing client communication (written and oral) for all applicable projects maintained by direct reports and as part of functional role, including the handling of issues or sensitive subjects that arise.
Providing guidance on the creation of deviations and OOS investigations to members of own team as well as other chemists/supervisors/managers. Supporting or leading QCA within or across departments.
Lead data interpretation and use conclusions to propose follow up experiments, as necessary, for Out of Specification investigations and deviations.
Expertise in the use of analytical instrumentation and application of technical guidance to junior analysts on method and instrument trouble shooting and communicating issues to department head.
Support Continuous Improvement initiatives within the QC group, identifying areas of potential approvement and leading projects, where applicable
Will provide feedback on efficiency initiatives performed in the department, and assist in finding ways to improve fiscal responsibility for hiring, resource allocation, and workload distribution.
Other duties as assigned
The Candidate:
BS or MS degree in Chemistry or other applicable scientific discipline required.
12+ years of applicable industry experience in either Analytical Development or Quality Control required.
6+ years of applicable laboratory experience and technical expertise on analytical procedures and all generated data required.
5+ years of managerial experience, history of managing tiered groups preferred
3+ years of GMP experience required.
Physical Requirements: Individual needs to be accessible to lab and office staff and able to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently
Pay:
The anticipated salary range for this role in California is $150,000 - $162,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why you should join Catalent:
Awesome employee activities: Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.
Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.
Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Several Employee Resource Groups focusing on Diversity and Inclusion.
Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment.
152 hours of PTO + 10 paid holidays.
Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
WellHub program to promote overall physical wellness.
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.