The laboratory groups at Catalent RTP are responsible for the support of pharmaceutical product development in a range of dosage forms both directly with customers and in collaboration with other Catalent facilities. This includes formulation development, structural chemistry, analytical support, and clinical trials material manufacturing.
II. Department Summary
As a member of the team, you will utilize your expertise to support the development of multiple pharmaceutical products for Catalent partners. An understanding of process chemistry, fate and purge studies, genotoxic impurity control, and general impurity identification is required Your efforts will include delivering high-quality scientific contributions by developing and validating spectroscopic or chromatographic methods as well as rapid and accurate execution of methods for release and stability. As a scientist and leader in our organization, you will be a key component of the engine that powers our operation, applying expertise in regulatory requirements for CMC submission. Supervisory experience in a fast-paced environment is a must. A high level of expertise in organic chemistry, as well as analytical chemistry and spectroscopic characterization techniques, is required. Experience with working in a highly GMP-regulated environment is preferred.
III. Job Summary
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.
IV. Specific Duties, Activities, and Responsibilities
•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 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
•All other duties as assigned.
V. Job Qualifications:
Education and Experience:
•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 Bachelor's and >12-15 years related experience, Master's and >9-15 years related experience PhD and >5-12 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 guidances for the customer and is capable of defending these positions to regualtory 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
•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.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
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, or protected veteran status.
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 [email protected]. 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.