Job Description
In this exciting role as a Senior Scientist, you will have responsibility for analytical test development, method verifications, and validation in support of new and existing combination product Quality Control. The Senior Scientist will require a variety of technical skills including HPLC, UPLC, GC, Dissolution/Elution (USP Apparatus 2), FTIR, GPC, and statistical analysis. The individual will make and record observations; perform calculations; and collect and prepare data for evaluation. This individual will perform technical and recordkeeping duties in conformance with company policies, current Good Lab Practices (cGLP), current Good Manufacturing Practices (cGMP), and technical procedures in Quality Control/Assurance and/or Research and Development group. In addition, the individual will be the liaison between the external laboratories that are doing testing with the internal stakeholders as the analytical/CMC lead ensuring product releases are done in a timely manner and all the regulatory compliance requirements are met.
ResponsibilitiesProvide technical input, oversight, and direction to assigned projects and activities in support of process improvements to current methods.Lead external laboratory collaborations including reviewing data packages, test results, lab investigations, and any method transfers.Coordinate external laboratory data and information with the internal teams for product release/annual stability.Write and review test methods, method verification/validation protocols, and method verification/validation reports.Participate in cross-functional teams as a representative of the Analytical Quality Control group.Support internal/external audits for analytical/CMC related topics.Provide mentoring and coaching to the Analytical Development staff when needed.Initiate, design, develop, execute, and implement scientific research projects.Investigate the feasibility of applying scientific principles and concepts to potential inventions and products.Plan and execute laboratory research.Maintain substantial knowledge of state-of-the-art principles and theories and contribute to scientific literature and conferences.Participate in the development of patent applications.Coordinate interdepartmental activities and research efforts.Essential SkillsAdvanced knowledge of analytical test development, method verification, and method validation.Experience with HPLC, UPLC, GC, Dissolution/Elution (USP Apparatus 2), FTIR, and GPC.Thorough knowledge and experience with cGMP and ICH guidelines.Experience in developing and validating analytical test methods.Ability to make and record observations, perform calculations, and collect and prepare data for evaluation.Strong understanding of current Good Lab Practices (cGLP) and current Good Manufacturing Practices (cGMP).Additional Skills & QualificationsDegree in Chemistry is preferred.Experience in advanced data analysis.Experience in project management.Minimum of 4 years of relevant experience with a Baccalaureate degree, or minimum of 2 years with an advanced degree.Work Environment
The work environment includes collaboration with both internal teams and external laboratories. The role involves adhering to company policies and regulatory compliance requirements. The job requires working under limited supervision, providing guidance and coaching to other employees, and occasionally managing projects. The position demands substantial knowledge of state-of-the-art principles and theories, as well as adherence to cGLP and cGMP standards.
Pay and BenefitsThe pay range for this position is $40.00 - $60.00
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Menlo Park,CA.
Application Deadline
This position will be accepting applications until Feb 1, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.