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 a Group Leader position for the Bioassay group within the Biopharmaceutical Support Services Department.
II. Department Summary:
As a member of the bioassay team, you will utilize your expertise to support the implementation of both cell-based and non-cell based bioassay techniques in support of the pharmaceutical industry. Your efforts will focus on delivering high-quality scientific contributions by developing and validating complex biological assays. As a scientist and leader in our organization, you will be a key component of the engine that powers our operation, applying expertise in the biological sciences . A high level of expertise in ELISAs and cell-based bioassays is required. Experience with working in a highly GMP-regulated environment is preferred. Additional experience with other immunoassay and molecular biology techniques, such as qPCR, SDS-PAGE and Western Blots is also preferred .
III. Job Summary:
Plans, conducts and directs scientific work on complex biologics projects, which may necessitate the origination and application of new and unique approaches. Plans and directs projects and supplies technical inspiration, leadership and consultation to direct reports and professional co-workers. May represent the organization in outside discussions and technical forums. Generally works with latitude for un-reviewed 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 - 5%
•Independently authors and approves technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures -10%
•Review technical documents for accuracy, thoroughness and regulatory compliance - 20%
•Trains, coaches or mentors others on technical, personal development or business issues -10% Supervises technical staff, including work assignments and performance and development management - 30%
•Responsible as project director on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business - 10%
•Identifies and independently drives department level improvements - 5%
•Support development of business strategies for multiple customers across multiple company sites - 5%
•All other duties as assigned - 5%
V. Job Requirements
Education and Experience:
•Doctoral degree, master's degree, or bachelor's degree in biology or a closely related biological science from a four-year college/university or equivalent education and training years of experience
•Bachelor's and >14 years related experience, Master's and >12 years related experience PhD and >10 years related experience, or equivalent education, experience and training
•Technical expertise in immunoassays and molecular biology techniques is required (ELISA, Multiplex Electrochemiluminescence Technology, SDS-PAGE, Western Blot, qPCR, Aggregation and Coagulation Assays)
•Technical expertise in cell culture and cell-based bioassays is preferred
•Statistical data analysis experience is required (SoftMax Pro, GraphPad Prism, StatLIA, SAS JMP)
•Microsoft Office proficiency is required
•GMP experience is required
•GLP experience is preferred
•Supervisory experience of 2 personnel is required
•Budget management experience is preferred
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 rapid learning of multiple unfamiliar principles or techniques with minimum training
•Ability to interpret and evaluate a variety of instructions furnished in written, oral, diagram, or schedule form
•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 conversation to an acceptable resolution
•May be accountable to meet business unit revenue targets
•Leadership development skills are required.
•Recognized by internal and external customers and direct reports as a subject matter expert with high personal credibility
•Can assess training needs and formulate development plans for direct reports
•Excellent motivator, well versed in team development
•Lead by example according to Catalent's values and culture
•Works directly with Business Development to win new business (conference calls, new customer meetings, some travel)
•Ability to interpret, provide and manage a variety of instructions furnished in written, oral, diagram, or schedule form across multiple work groups and departments
•Understands the details of regulatory CMC filing package and the analytical and formulation documentation required therein. Has the ability to write and review documents for regulatory 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.