Sr. Quality Control Analyst (Pharma)

Pace® Analytical Services•Waltham, MA

10d•Onsite

About The Position

Responsible for providing or overseeing the analysis, administration and oversight of comprehensive chemistry/biochemistry policies, programs and practices; may provide feedback and guidance to clients regarding the analysis of materials, products and/or devices utilizing complex to specialized professional and technical knowledge of chemistry/biochemistry/formulation development or related equipment, testing, and procedures. May design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials. May develop and optimize manufacturing processes for drug products. May interpret analytical data to guide formulation and process development decisions.

Requirements

Bachelor's degree in chemistry/biochemistry, or a closely related field.
5-8 years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience.
Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development.
Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures.
Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns.
Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations.
Understanding of broad testing tools, equipment, and calibration.
Computer applications and systems related to the work.
Principles and practices to serving as an effective project team member.
Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
Correct business English, including spelling, grammar, and punctuation.
Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas.
Overseeing and administering broad and varied chemistry/biochemistry/formulation functions.
Ability to operate and train others in analytical instruments and manufacturing equipment.
Training others in policies and procedures related to the work.
Serving as a team member and the development and management of projects.
Operating in a both a team and individual contributor environment.
Interpreting, applying, and explaining applicable laws, codes, and regulations.
Preparing advanced to expert functionals reports, correspondence, and other written materials.
Using initiative and independent judgment within established department guidelines.
Using tact, discretion, and prudence in working with those contacted during the work.
Performing effective oral presentations to large and small groups across functional peers and the department.
Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
Establishing and maintaining effective working relationships with various individuals contacted in the work.

Nice To Haves

Master's or PhD degree is strongly preferred.

Responsibilities

Serves as a lead to staff to include providing work direction, guidance, and training.
Overseeing or reviewing, completing, and processing comprehensive types of forms, documents, databases, and related materials and information.
Provides complex to specialized analysis in support of various testing materials, products and/or devices utilizing various analytical instrumentation; follows Standard Operating Procedures and methods to perform testing.
Provides complex to specialized review, analysis, interpretation, and documentation of testing results.
Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
Provides training and guidance on analytical tests, methods, and instrumentation, as required.
Provides complex to specialized analysis, interpretation and counsel to clients, staff, management, and functional leaders regarding chemistry/biochemistry policies, programs, and practices; involves broad operations and leading implementation and change.
Analyzes and reviews complex to specialized operations, results, feedback, and related chemistry/biochemistry/formulation information on an ongoing to as needed basis to determine trends, draw conclusions, interpret findings, and presents results, proposals, and recommendations to management and/or clients.
Assists with developing or participating in chemistry/biochemistry/formulation or cross functional project or program objectives, which includes proposed budgets, timelines, materials, personnel, and other project requirements, receives direction, and presents information to management and/or clients.
Develop validate and transfer analytical methods.
Provide routine and non-routine analysis using instruments such as HPLC, GC, LC-MS, and FTIR, DD-PCR, among others.
Design and develop robust and scalable formulations for small molecules and biologics for early-stage clinical trials.
May develop and optimize manufacturing processes for drug products.
Ensure all activities adhere to SOP's, regulatory guidelines, GLP and GMP standards.
Contributes to the efficiency and effectiveness of the department's service to its customers by offering suggestions and directing or participating as an active member of a work team.
Promotes and supports the overall mission of Pace Analytical by demonstrating courteous and cooperative behavior when interacting with customers and staff; acts in a manner that promotes a harmonious and effective workplace environment.