Group Lead, AR&D

St. Petersburg is Catalent’s primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

The Analytical Research & Development (AR&D) laboratory supports, development and validation of methods analytical test methods, evaluation and testing of raw materials, and testing of non-commercial materials to support product development. The department provides analytical services to manufacturing, process development, validation and new material qualifications. All activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and St. Petersburg’s Quality departmental policies.

The Group Leader, Analytical Research & Development role is critical to our patients. The role oversees both customer dual source material qualifications for development programs as well as customer development programs for global markets. Ensuring starting material is suitable for use is one of the foundations of assuring programs are developed with regulatory vigor and acceptable limits to assure Patient safety. Quality, safety and on-time delivery is a must to be successful in this role. If you share a passion for patient care in the growing world of pharmaceutical manufacturing and would like to be part of a global drug development and delivery leader, then this role is for you.

The Role

• Prepare and set the daily work schedule for the Analysts by working with the Project Management and Customers to determine business needs. The Group Lead directs and motivates the Analysts to meet or exceed the needs of the organization. The Group Lead guides the Analysts by setting Laboratory targets and by providing clear instruction and guidelines for performance.
• Manages new product, method and technology transfers. Oversees all analytical method transfer activities as required by their area.
• Identifies and implements process improvements that will reduce cycle time to test and release products.
• Sets yearly goals and objectives for direct reports.
• Prepares and conducts performance evaluations for direct reports.
• Supervises Laboratory personnel for the following activities: Analysis of finished products and Validation

The Candidate

• Bachelor’s degree in a scientific field with 10 years in lab; nine in GMP, a Master’s degree in a scientific field with eight years in lab; six in GMP, or a Doctorate in a scientific field with five years in lab; 3 in GMP
• Minimum of four years in people management
• Demonstrated history of method development and/or validation.
• Demonstrated critical thinking ability with experience in conducting and writing laboratory investigations.
• Demonstrated leadership skills including demonstrated ability to self-start and work independently at the highest level with little supervision; Demonstrated ability to lead and work effectively with cross-functional teams; Demonstrated people management and development skills.

Work Environment

• Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance.
• Be accessible to manufacturing floor and office staff and to use required office equipment.
• Vision requirements include ability to differentiate color (Pass the Ishihara Color Vision Screening) and obtain 20/30 acuity in both far and near vision with or without corrective lenses. For Catalent’s in-house screening, the acceptable score is to identify at least 4 of 6 numbers in the circles.
• Use of computer monitor screen frequently
• Individual’s primary workstation is in the office area, where the noise level is low. Employee may occasionally be present in the lab and on the manufacturing floor where the noise level is low to moderate.

Why you should join Catalent

• 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 bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories

We will identify candidates based on the following Catalent Competencies:

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

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.

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 spam@catalent.com for us to investigate with local authorities.