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 Stability team, you will utilize your experience to analyze samples using HPLC, dissolution, and Karl Fischer in support of the pharmaceutical industry. As a member of the stability team, your efforts will focus on assisting rapid and accurate execution of methods for release and stability. Knowledge and experience in HPLC is required.
Additional experience with dissolution, Karl Fischer, UV or other characterization techniques, such as FTIR or HIAC, is preferred.
III. Job Summary
Usually works with some supervision, conferring with superior on unusual matters. May be assisted by laboratory technicians/assistan ts or associate level scientists. Assignments are broad in nature, requiring originality and ingenuity.
Has appreciable latitude for un-reviewed action or decision. He/she may direct projects and employees, taking on a technical lead role. Comply with divisional and site Environmental Health and Safety requirements.
IV. Specific Duties, Activities, and Responsibilities
•Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/
•site performance standards and metrics Authors 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 management
•Responsible as Project Director with responsibility for project outcome and customer interaction
•Executes efficiency improvement project with guidance
•Identify and recommend business opportunities on a project specific basis
•All other duties as assigned.
Education and Experience:
•Degree in chemistry or closely related physical science; Bachelor's degree with 7 - 9 years related experience, or equivalent education, experience and training; Master's degree with 4 - 6 years related experience; Doctorate Degree
•with 0 - 2 years related experience
•Method Development and Method Validation experience is required
•HPLC experience is required
Knowledge, Skills and Abilities:
•Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
•Ability to learn and retain technical information
•Proactively address work issues at both an individual level and a team level
•Develop and execute complex procedures or methods with high quality
•Becoming familiar with drug development milestones and their context
•Recognizes and elevates changes in project scope or execution for review by project director
•Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient
•Propose deviations from established procedures and methods based upon sound judgment.
•Excellent written and verbal communications skills with internal and external customers Supervisory skills are expected
•for Scientists with direct reports
•Can organize and manage teams chartered to address resolution of lab issues or special projects with general
•Lead by example according to Catalent's values and culture
•Can assess training needs and formulate development plans for subordinates
•Recognize unmet customer needs
•Can effectively back-up supervisor to address limited technical or business issues with prior instructions
•Strategy is focused on personal and team time management and efficiency
•Well organized with ability to multitask
•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.