Assoc Research Scientist – qNMR, HPLC, KF

Description

You will join a Laboratories Functional Service Partnership team, which places long-term groups of scientists inside customer organizations to support drug development.

The company is a contract research organization running laboratory, digital and decentralized clinical trial services, with clinical trials in more than 100 countries.

The role is fully onsite at a customer site in Boston, Massachusetts. Applicants from anywhere in the US are welcome.

Responsibilities

• Work with the team to design and oversee analytical activities for drug substance process development in early phases.
• Find critical in-process control problems and build suitable IPC methods.
• Act as the subject matter expert for drug substance analytics with contract manufacturing and testing labs.
• Develop analytical methods that suit early-stage pharmaceutical development.
• Study chemical and solid-state development to identify and document critical factors that affect quality, method performance and analytical work.
• Present to cross-functional teams and explain critical analytical issues and their solutions.

Requirements

• Hold a bachelor's degree in a lab science such as chemistry, biochemistry, material science, immunology, biology, molecular biology or a similar field.
• With a bachelor's degree, have at least 6 years of comparable experience that gives you the knowledge, skills and abilities for the role (ARS level).
• With a master's degree, have at least 4 years of comparable experience that gives you the knowledge, skills and abilities for the role.
• With a PhD, have at least 2 years of comparable experience that gives you the knowledge, skills and abilities for the role.
• In some cases, a combination of education, training and directly related experience will be considered sufficient to meet the requirements.
• Excellent verbal and written communication skills are essential.
• Experience or working knowledge of control strategy development.
• Solid understanding of cGMP, ICH, FDA and USP guidelines, including ICH guidance on controlling impurities: organic, residual solvents, elemental, DNA-reactive (including ICH M7 option 4 / in silico control) and nitrosamines.
• Hands-on skill with modern analyses for small-molecule pharmaceuticals, especially chromatography (HPLC/UPLC), KF, qNMR and similar.
• Able to work well both in a team or matrix setting and independently.
• Able to work in a fast-paced setting, manage priorities, communicate outcomes and keep several projects on schedule.
• Able to communicate, receive and understand information and ideas with diverse groups in a clear and reasonable way.
• Able to work upright and stationary or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Proficient with standard office equipment and technology, and able to learn new tools.
• May be exposed to potentially hazardous elements, including infectious agents typical of healthcare or laboratory settings.
• Able to perform under pressure while handling multiple projects or activities.

Conditions

Base pay for this role in Massachusetts is $110,000.00 to $115,100.00.

Full-time day shift, Monday to Friday, 8am to 5pm EST.

Relocation assistance is not provided, so any relocation costs are the candidate's responsibility.

Candidates must be legally authorized to work in the United States, as no sponsorship is offered.

All work follows Good Manufacturing Practices (GMP) safety standards.

Benefits

• Eligible for a variable annual bonus based on company, team and individual performance, in line with company policy.
• Choice of national medical and dental plans, a national vision plan and health incentive programs.
• Employee assistance and family support programs, commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO), 10 paid holidays a year, paid parental leave of 3 weeks for bonding and 8 weeks for caregiver leave, accident and life insurance, and short- and long-term disability under company policy.
• Retirement savings, including a competitive 401(k) plan.
• Employee Stock Purchase Plan (ESPP) letting eligible colleagues buy company stock at a discount.