I. Position Overview:
This Sr. Scientist position will be responsible for leading activities of formulation development. This position will be capable of screening formulation, performing biophysical characterization testing, and designing and executing stability studies to support formulation development. The Sr. Scientist will serve as a formulation lead for technical advice and perform multiple complex projects at a time. This position is able to design new approaches to attack complicated problems encountered during formulation development.
II. Specific Responsibilities:
This position will lead formulation development activities to support early stage drug substance development. This position will independently evaluate, select and apply advanced analytical techniques to evaluate and define new formulations to stabilize protein drugs.
- Designs and executes formulation protocols
- Develops/optimizes biophysical techniques for formulation, including HPLC, CE, DSC, MFI, CD, and light scattering methods to characterize protein/mAb
- Performs biophysical testing to support biologics formulation development
- Responsible for designing and executing stability studies
- Troubleshoots and solves HPLC, CE, and other instrument problems
- Acts as the technical lead for Client development projects, communicates project status and effectively provides technical explanation/rationalization
- Critically analyzes complex data, interprets and integrates experimental results with project objectives
- Stays current with respect to the latest advancement in protein analytical techniques and protein formulation
- Accurately ships samples to clients and fills out appropriate paperwork
- Makes decisions affecting project directions and maintains project timelines
- Performs general lab housekeeping, including cleaning/sterilizing of lab and lab materials, disposal of trash and recyclables, ordering and stocking supplies, etc.
- Accurately completes routine and preventative maintenance on laboratory equipment, including qualification and calibration
- Actively participates in team meetings
- Mentors others, as assigned
- Performs lab overview for client tours and internal clients (shadowing)
- Other duties as assigned
III. Position Requirements:
- Ph.D. Chemistry/Biochemistry or related with at least 2 year biologics formulation experience in biotech industry or MS with over 5 year experience
- B.S/B.A. with over 8 year experience
- Experience in early stage formulation development for drug substance
- Hands-on experience in developing HPLC/UPLC, CE, DSC, MFI, CD, and light scattering methods for protein/mAb analysis
- Expertise in designing protein stability studies to support protein formulation
- Good documentation practices (GDP)
- Experience writing standard operating procedures and reports
- Experience mentoring junior staff regarding laboratory procedures
IV. Dimensions of Position:
Scope of Responsibility:
- Direct Reports: NA
- Total Site Staff (includes directs): NA
V. Physical, Technical and Behavioral Requirements of the Position:
- Ability to perform a variety of laboratory tasks.
- Ability to transfer knowledge to others via training or mentoring of staff; demonstrated ability to guide others through communication and learning.
- Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
- Ability to provide ideas, introduce new technology, and drive process improvements. Work with other groups to develop, qualify and transfer methods accordingly.
- Ability to identify new opportunities within client base and ability to work with Business Development to pursue opportunities.
- Ability to attend training and apply learning on routine operation, maintenance and theory or laboratory instrumentation, SOPs, and regulatory guidelines.
- Ability to use Excel, Word, and other office systems.
- Ability to review data to ensure data is well organized with complete documentation.
- Ability to write, edit and review SOPs and reports with guidance.
- Ability to problem solve and execute/monitor corrective action with guidance.
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. 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 Jobs@catalent.com. 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