Sr. Quality Control Analyst

Waltham, Massachusetts
Pace Life Sciences
About Us

Pace Life Sciences

Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.

Job Description

SUMMARY:

This candidate will be responsible for laboratory activities in support of process development and industrialization and ensure the characterization of mRNA. These analyses include HPLC, ELISA, qPCR, western blot and more that support the process development

ESSENTIAL FUNCTIONS:

• Perform analytical testing and data review of batch release, in process and/or stability samples of mRNA drug substance in cGMP compliant laboratory.
• Executes routine procedures based on biochemistry methodologies, such as HPLC, UPLC, SoloVPE.
• Execute routine procedures based on bioassay methodologies, such as plate-based assays (ELISA, ddPCR, ribogreen), gel electrophoresis, western blot and cell based assays.
• Support the laboratory start-up activities, participate in validation activities.
• Authors revisions to SOPs for managerial review and approval.
• Execute troubleshooting with minimal guidance from supervisor or senior team members.
• Acts as trainer for specific methodology, responsible for training less experienced analysts on assays of expertise.
• Support qualification and validation testing of QC methods in area of expertise.
• Support and/or lead lab investigations.
• Participate in continuous improvement of laboratory safety and quality compliance.
• Assist with the development of new methods and processes.
• General laboratory activities and instrumentation including pipetting, preparation of solutions/samples/media, and operation of pH meters, autoclaves and analytical balances.
• General laboratory upkeep and supplies maintenance.

QUALIFICATIONS:

Education and Experience:

• BS or MS in analytical chemistry, biochemistry, or biotechnology or equivalence
• BS with 3+ years or MS (0+ years) of professional experience in the vaccine or pharmaceutical industry in the field of QC analytics or R&D.
• Preferred 2 years of experience in cGLP or cGMP lab
• Expertise in biochemical and bioassay techniques
• Proficient with lab software (LIMS, Empower, Bio-Rad Image Lab)
• Working knowledge of regulatory standards as they apply to cGMP laboratories.
• Excellent verbal and written communication skills.
• Experience with Microsoft Office 365.
• Good deductive reasoning and initiative to solve problems.
• Able to handle multiple assignments concurrently, self-motivated, and results driven.

About SIS at Pace

Like Pace , our customers are continually innovating and looking for quality candidates to support their important work. As a member of the Pace Scientific Insourcing Solutions team, you will have the opportunity to work directly with industry leaders who have scientific needs both inside and outside of the laboratory.

Additional Information

Benefits

80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.

Equal Opportunity Employer

Pace provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Work Schedule M-F, 8-5pm