Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our clients to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

This position provides analytical support for cleaning verification activities and the testing of materials in support of R&D activities and GMP manufacture of small molecule Drug Substance and Drug Product.

Analytical Techniques

• HPLC
• HPLC-MS
• FTIR
• KF
• Conductivity
• ICP
• ICP-MS
• IC
• GC
• UV
• pH
• Wet Chemistry (USP)

Analytical Duties

• Developing and qualifying (validating) analytical methods capable of detecting low levels of residues on manufacturing equipment.
• Perform swab/rinse sampling on manufacturing equipment in accordance to the qualified method.
• Perform analysis on cleaning verification samples to determine drug and detergent residues.
• Communicate analysis results to your supervisor and to the appropriate teams.
• Support analysis of raw materials, excipients, packaging components, starting materials, and packaged clinical supplies using various analytical techniques.
• Residual Solvents testing by GC.
• Routine Water Analysis by KF.
• Compile new specifications for raw materials, excipients, and packaging components.
• Assist in the testing of drug substance and drug products as needed.

Our 4i Values:

Integrity - Innovation - Intensity - Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!

Education and Experience:

• Bachelor's degree with a preference in Pharmaceutical Chemistry, Pharmaceutics, or equivalent and relevant formal academic / vocational qualification.
• Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• 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:

• At least one year of experience in a GMP regulated lab is required
• Demonstrated experience with instrumentation including, but not limited to, HPLC, KF, GC, LCMS, dissolution testers, titrators, and FTIR.
• Ability to work independently or as part of a team utilizing self-motivation, adaptability, and a positive attitude
• Strong computer, scientific and organizational skills.
• Ability to learn new techniques, perform and prioritize multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies and procedures
• Excellent judgment, troubleshooting and problem solving skills
• Good written and oral communication skills
• Time management and project management skills
• Ability to work in a collaborative work environment with a team

Working Environment:

PPD, part of Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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.
• As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

The salary range estimated for this position is $23.00 hourly - $41.00 hourly. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:

• A choice of national medical and dental plans, and a national vision plan
• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
• Tax-advantaged savings and spending accounts and commuter benefits
• Employee assistance program
• 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, short- and long-term disability, and volunteer time off in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Compensation and Benefits

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