Work ScheduleFirst Shift (Days)
Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting
Job DescriptionSenior Scientist - Method Transfer CMOShift: Full-Time; Monday - Friday; 8am-5pm EST
ONSITE: This is a fully onsite role based at our customer's site in
(insert location - i.e. Boston, MA). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Key responsibilities:- Method transfers for small molecule drug substance to various CMOs or between internal groups
- Method validation or co-validation to support late-phase and commercial projects
- Authoring/reviewing documentation to support new and existing commercial products (methods, SOPs, transfer protocols/reports, lab notebooks, technical reports, etc.)
- Independently managing CMOs for manufacturing of GMP starting materials, intermediates and drug substances, leading analytical OOS/OOT investigations/assisting process investigations and providing scientific-sound solutions to root cause identification of quality events
- Reviewing CMO's analytical raw data and result reports including both release and stability data
- Commercial data collection, interpretation, reviewing, trending, and report generation to support continuous process verification
- Continuous method improvement through commercial change control procedures
Education and Experience: - Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
- Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years')
- OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
- OR PhD
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities: - Experience with small-molecule drug substance IPC, release and stability methods
- Experience in an analytical development or technical operations role, supporting new product development and commercialization.
- Experience with chromatography methods such as HPLC, GC, MS, and other common analytical techniques used in pharmaceutical analysis
- Experience with compendial methods for analysis (e.g. KF, elemental impurity testing, and identification by spectroscopy)
- Knowledge of cGMP's (e.g. Quality Control), ICH guidelines and associated CMC regulatory considerations in a pharmaceutical setting
- Strong communication and technical writing skills
- Must be a committed team player and collaborator
Working Environment: Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Compensation and BenefitsThe salary range estimated for this position based in Massachusetts is $95,000.00-$110,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
