The role of the Group Leader plans, conducts and directs scientific work on complex projects necessitating the origination and application of new and unique approaches. The position will lead all planning and directing projects and supplies technical inspiration, leadership and consultation to professional co-workers. The Group Leader will represent the organization in outside discussions and technical forums.
The Group Leader will report directly to the Manager, Quality Assurance Operations and will reside over the 2nd and potentially 3rd shift teams.
Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries. https://www.youtube.com/watch?time_continue=1&v=65rz3LwTPX8
The Role/Daily Duties:
Develop and execute laboratory workplans/schedules for self and team, using customer milestones and Division/site performance standards and metrics.
Independently authors and approves technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures.
Review technical documents for accuracy, thoroughness and regulatory compliance.
Trains, coaches or mentors others on technical, personal development or business issues - supervises technical staff, including work assignments and performance and development management.
Responsible as project director on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business.
Identifies and independently drives department level improvements.
Support development of business strategies for multiple customers across multiple company sites.
Doctoral degree, master's degree, or bachelor's degree in chemistry or closely related physical science from a four-year college/university or equivalent education and training years of experience.
Bachelor's and >18 years related experience, Master's and >15 years related experience PhD and >12 years related experience, or equivalent education, experience and training.
Knowledge, Skills and Abilities:
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs.
Advanced project management skills are routinely practiced for multiple concurrent projects of moderate to high complexity.
Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
Has substantial breadth/depth of technical acumen in multiple techniques with significant expertise in one or more techniques and can understand their application in context of pharmaceutical services offerings.
Provides reliable/defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies.
Excellent written and verbal communications skills with internal and external customers.
Able to lead difficult discussions with customers and drive the conversation to an acceptable resolution.
Excellent motivator, well versed in team development.
Works directly with Business Development to win new business (conference calls, new customer meetings, some travel).
Understands the details of regulatory CMC filing package and the analytical and formulation.
Ability to work effectively under pressure to meet deadlines.
May publish or present externally.
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.
Working Conditions and Environment:
This position will be stationed in an office and laboratory environment involving work near moving/mechanical parts; working around various chemicals including biologics, active pharmaceuticals, beta-lactams and radioactive materials; and other conditions reasonably expected due to the nature of the work required.
Position may require domestic or international travel.
Flexibility required to work outside normal working hours of 8:00 a.m. 5:00 p.m.
We will identify candidates based on the following:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Join a high growth and fast paced organization with a people focused culture
Global exposure, defined career path and annual performance review and feedback process
Competitive Insurance, 401K, PTO and paid holidays!
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. More products. Better treatments. Reliably supplied.
Visit www.catalent.com/careers to explore career opportunities, or contact us at
+1 877 503 9493.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.