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 Biophysical Characterization and Analysis team, you will utilize your expertise to support the implementation of HPLC / HPLC-MS methods and other structural characterization techniques in support of the pharmaceutical industry. Your efforts will focus on delivering high-quality scientific contributions by developing and validating HPLC or HPLC-MS methods as well as rapid and accurate execution of methods for investigation, release, and stability. As a Scientist and developing leader in our organization, you will be a key component of the engine that powers our operation, applying expertise in analytical chemistry and biochemistry.
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
V. Job Primary Location
Development & Clinical Services
Education and Experience:
Doctoral degree, Masters degree, Bachelors degree, or Associates degree in chemistry or closely related physical science from a four-year college/university or equivalent education and training
PhD and 0-2 years related experience, MS and 4-6 years related experience, BS and 7-9 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
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 resource utilization
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 management guidance.
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.