PPD Senior Research Scientist - Synthetic Process Chemistry in FSP Boston MA, Massachusetts
*EXPECT MORE FROM YOUR CAREER
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD Laboratories FSP. PPD Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits/advantages of being a part of PPD.
As aSenior *Research Scientist, you are a highly motivated, scientifically driven and enthusiastic individual who will design and develop chemistry on a synthetic project while conducting laboratory experiments to enable the delivery of compounds to support toxicology studies, human studies, and technical transfer information internally and to contract research organizations externally. You may develop new chemistry, improve existing chemistry and demonstrate such chemistries by delivering compounds at expected purity and batch size for the appropriate phase of development.
Additional responsibilities for the role on site at a major pharma/biotech company:
• Considered a scientific leader throughout their career as evidenced through patents and/or publications.
• Design and perform synthetic organic experiments efficiently, independently and in a fit-for-purpose fashion for the stage of development (pre-clinical through process validation).
• Perform reaction process monitoring using a variety of analytical methods and work with analysts to develop sufficient methods.
• Generate effective hypotheses to pursue synthesis or manufacturing goals and set new experimental direction.
• Has a proven track record of scaling-up and delivering kg quantities of experimental drug substance in the appropriate physical form.
• Understands and is able to develop synthetic plans for synthesis development of molecules.
• Identifies impact of results on the overall process development timeline.
• Provides technical recommendations regarding process chemistry by assisting other chemists in the department and/or articulating issues to upper management.
• Makes conceptual contributions to development activities and scientific strategies.
• Develops novel and creative solutions to overcome synthetic and manufacturing obstacles.
• Employs new principles and concepts from other fields to promote new progress in synthesis.
• Ability and track record of successfully working in cross-functional teams.
• May motivate or supervise other process chemistry staff on their day to day experiments and ensure compliance of the team with relevant regulations and SOPs.
• Experience in writing and transferring developed technology to outside CROs and working with suppliers to solve chemical issues for compound delivery.
• Author reports and regular updates at appropriate project intervals while maintaining excellent and reproducible laboratory records.
Grow your career within the scientific ladder, pursue project management, or develop into a leader. These are just a few career pathways available once you chose to Be with PPD.
Join PPD in our relentless pursuit of excellence - apply now!
Education and Experience:
Bachelor's degree in Chemistry, Organic Chemistry, Medicinal Chemistry or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years’) or Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 8 year)
PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6 year)
Previous relevant process chemistry experience strong preferred
Knowledge, Skills and Abilities:
Knowledge of general chemistry and separation science - HPLC and NMR
Familiar with SOPs and GMPs and ensure compliance with all applicable regulations and SOPs.
Ability to independently perform root cause analysis for method investigations
Ability to draft CMC sections of INDs or CTAs is a plus
Proven ability in drafting, reviewing and submitting required documentation pertaining to the development and preparation of drug substances under cGMP environment is desirable.
Proficiency on technical operating systems
Proven problem solving and troubleshooting abilities
Ability to multitask to effectively manage multiple activities/projects
Proven ability in technical writing skills
Time management and project management skills
Good written and oral communication skills
Ability to work in a collaborative work environment with a team
Ability to train junior staff
Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
Occasional drives to site locations, occasional domestic travel.
Exposure to biological fluids with potential exposure to infectious organisms.
Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
Personal protective equipment required such as protective eyewear, garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
Occasional mobility needed.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.
Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
*Job: Lab Operations
*Organization: CGMP Lab-United States (LBGUS)
*Title: Senior Research Scientist - Synthetic Process Chemistry
*Location: Massachusetts-FSP Boston MA
*Requisition ID: 144934