Catalent Pharma Solutions in Kansas City, MO is hiring a Group Leader, Microbiology
. The Group Leader role is critical to the Microbiology group and the incumbent will act as a primary technical lead interfacing with customers, writing protocols and communicating with the Microbiology Manager and other internal stakeholders to ensure incoming projects are ready to execute. Primary duties include performing microbiological method development and verification, testing of raw materials and sterile and non-sterile pharmaceutical dosage forms, and general support activities within the Microbiology group in the Quality Control Department. An individual in this role functions as a microbiology technical lead, interacts with external and internal customers for project support, and mentors or provides technical guidance to junior analysts. Responsibilities also include coordinating, performing and/or supporting instrument/equipment qualification activities, as well as associated maintenance and calibration programs. The individual will author and/or revise procedures/methods, as appropriate. Supervisory responsibilities include oversight to a group of 2 to 5 analysts as a Group Leader. This is a full-time position: Monday - Friday, days from 8am-4:30pm.
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacturing. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent is committed to a Patient First culture through excellence in quality andcompliance, and to the safety of every patient, consumer, and Catalent employee. The Role
- Plan and perform method development/validation, routine microbiological testing (Microbiological Examination of Non-sterile Products, Sterility Testing, Antibiotic Potency, and Antimicrobial Effectiveness Testing) as assigned, and ensure compliance to applicable compendia and/or regulatory guidance.
- Communicate effectively with both internal and external customers, peers and supervising manager to facilitate the smooth conduct of project activities and to assure project timeline understanding and deliverable are met, as appropriate.
- Function as a group lead and provide technical guidance to junior analysts.
- To maintain awareness of cGMP's, industry standards, modern techniques and their application to pharmaceutical sciences activities.
- Author and/or revise procedures/methods, as appropriate.
- Perform technical review and verification of peers' analytical data in accordance with SOP's.
- Generate appropriate Certificates of Analysis and Analytical Results Forms, as applicable.
- Participate in microbiology-associated laboratory and deviation investigations, assure investigations are appropriately documented.
- Coordinate, support and/or perform equipment/instrument calibration, preventative maintenance and qualification activities.
- Function as a back-up to the manager, as needed.
- All other duties as assigned.
Why you should join Catalent:
- Education: Bachelors of Science in Microbiology or closely related discipline, 8+ years of microbiology laboratory experience - OR - Master's Degree in Microbiology or closely related discipline, 5+ years of Microbiology experience
- Industry experience as a microbiologist, strong leadership and project management skills, and previous supervisory experience are desirable.
- Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
- Executes procedures or methods of moderate complexity with high quality
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- Mathematical and scientific reasoning ability
- Basic understanding of instrument operations and troubleshooting skills in multiple techniques
- Ability to identify aberrant/out of spec data and limited interpretation of data expected
- Excellent written and verbal communications skills with internal and external customers
- Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently. May require the use of a respirator.
Catalent offers rewarding opportunities to further your career!
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- 19 days of PTO + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Employee Stock Purchase Program
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive salary with quarterly bonus potential
- Community engagement and green initiatives
- Generous 401K matchand Paid Time Off accrual
- Medical, dental and vision benefits effective day one of employment
- Tuition Reimbursement
- GymPass program to promote overall physical wellness
- Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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 email@example.com for us to investigate with local authorities.