The Sterile Formulation Development group at Catalent RTP is responsible for the support of pharmaceutical product and formulation development in a range of injectable dosage forms both directly with customers and in collaboration with other Catalent facilities. This includes formulation development, process development and analytical support.
As a senior member of the formulation development team you will utilize you expertise to develop novel formulations for injectable drug products (intravenous, intramuscular and subcutaneous) and ophthalmic drug products (injections and topical delivery). Formulation development experience with large biomolecules including antibodies, proteins and peptides is a requirement. The candidate should be proficient in the use of analytical tools to characterize the formulations developed. Analytical tools include, but are not limited to RP-HPLC, SEC-HPLC, Dynamic light scattering, and UV-VIS. The successful candidate will have demonstrated experience with developing formulations for preclinical through commercial phases of the product lifecycle. Experience with small molecule parenteral formulation development is a plus, but is not required.
This position is responsible for planning, conducting and directing scientific work on extremely complex projects necessitating the origination and application of new and unique approaches. He/she plans and directs projects and supplies technical inspiration, leadership and consultation to professional co-workers. He/she may represent the organization in outside discussions and technical forums. He/she generally works with latitude for unreviewed action or decision. Comply with divisional and site Environmental Health and Safety requirements.
Specific Duties, Activities, and Responsibilities
1. Develop and execute laboratory workplans/schedules for self and team, using customer milestones and Division/site performance standards and metrics
2. Independently authors and approves technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures.
3. Review technical documents for accuracy, thoroughness and compliance
4. Trains, coaches or mentors others on technical, personal development or business issues
5. Supervises technical staff, including work assignments and performance and development management
6. Responsible as project director on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business
7. Identifies and independently drives department level improvements
8. Support development of business strategies for multiple customers across multiple company sites
9. All other duties as assigned.
Education and Experience:
• Bachelor's degree in chemistry or closely related physical science and 12 - 15 +years, or quivalent education and training; Master's degree with 9 - 15 years related experience, equivalent education, experience and training; Doctorate Degree 5 – 12 years related experience
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 guidances for the customer and is capable of defending these positions to regulatory agencies
• Mathematical and scientific reasoning ability
• Capable of rapidly learning multiple unfamiliar principles or techniques with minimum training
• Well organized with ability to handle and direct multiple activities simultaneously
• Excellent written and verbal communications skills with internal and external customers
• Ability to communicate complex technical information to non-technical audiences
• Able to lead difficult discussions with customers and drive the to an acceptable resolution
• May be accountable to meet business unit revenue targets
• Leadership development skills are expected.
• Proactively identifies and implements new technologies and understands their impact on Catalent offerings
• Recognized by internal/external customers as subject matter expert with high credibility
• Excellent motivator, well versed in team development
• Lead by example according to Catalent's values and culture
• Work with Business Development to win new business (conference calls, customer meetings, travel)
• Ability to interpret, provide and manage a variety of instructions furnished in written, oral, diagram, or schedule form across multiple work groups
• Understand the details of regulatory CMC filing package and analytical and formulation documentation required. Has the ability to write and review documents for regualtory filings
• 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.