Description

In this position, you will work on the development of analytical methods, protein characterization, and assist formulation development and stability programs for DS & DP. You will work with a team to support and expand analytical development, formulation development and stability to help advance novel cancer therapies into human clinical studies. This is a laboratory position and you should be hands-on and able to work independently. The ideal candidate is also versed in GxP lab practices, including good documentation practices. The position will also be responsible for performing routine analytical testing in a quality regulated environment.

Summary of Key Responsibilities:

• Performs analytical sample analysis in support of process development using multiple techniques including ELISA, HPLC, CE, UV-Vis, etc.

• Familiar with Empower, Maurice, Waters/Thermo Fisher HPLCs, Softmax, Plate readers

• Aids in analytical testing for release & stability testing of drug substance, raw materials, intermediates, and drug product

• Help draft test methods for routine sample analysis

• Help identify analytical science capabilities and technology tools needed to enable research, manufacturing, process development, QC testing, and new drug candidate formulation development

• Helps maintain and organize the laboratory environment including samples, reagents, and instruments

• Assists analytical method transfer, qualification and validation to commercial QC and as needed for contract laboratories

• Assists development of scientifically sound and data driven specifications

• Helps prepare and delivers technical reports, documents, batch analyses, analytical methods, reference standard, etc. for regulatory submissions

• Knowledge of cGMP regulations

  Skills & Qualifications

• Must have experience working with HPLC, CE, and ELSIA in a quality control lab

• Ideal candidates have experience working at a CDMO

• Ability and track record of successfully working in cross‐functional teams to progress projects as a representative of CMC team

• Ability to navigate and be successful in a fast‐paced, matrixed work environment

• Desire to be a part of a highly innovative company aimed at helping patients with serious diseases

• A successful candidate must possess exceptional attention to detail, organizational, interpersonal, and communication skills, and demonstrate critical thinking and problem-solving ability.

• Must have the ability to multi-task to meet critical deadlines and the independent initiative to solve interdisciplinary problems.

• Candidate must be sharp, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.

• Must enjoy working in collaboration with others and small teams to achieve goals through effective building of relationships with co-workers.

Experience Level

Intermediate Level

Pay and Benefits

The pay range for this position is $28.00 - $36.00/hr.

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 fully onsite position in Durham,NC.

Application Deadline

This position is anticipated to close on Apr 3, 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 & Inclusion

At 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 people

The 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.