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Senior Process Development Associate

Job Description

As a Senior Associate Process Development, you will be responsible for supporting technology transfer, process validation, and plant start-up. In this non-laboratory-based role, you will work cross-functionally within operations, leveraging your process development experience to drive efficient and scalable processes. You will collaborate with other site functions and network drug substance teams to achieve plant goals.

Responsibilities

+ Support technology transfer and process validation.

+ Participate in plant start-up activities.

+ Work cross-functionally to drive efficient process development and scalable understanding of processes.

+ Collaborate with site functions and network drug substance teams to achieve plant goals.

+ Apply engineering principles and statistical analysis to resolve complex issues.

+ Draft protocols and reports, utilizing strong written and verbal communication skills.

Essential Skills

+ Process development experience.

+ GMP (Good Manufacturing Practices) knowledge.

+ Project management skills.

+ Technology transfer experience.

+ Downstream purification and protein purification experience.

+ Experience with process scale-up.

+ cGMP experience.

Additional Skills & Qualifications

+ 2 years of proven experience in a technical role supporting biotechnology processes within regulated environments.

+ Knowledge of biologics purification processes.

+ Experience in process scale-up technology transfer and process validation.

+ Familiarity with operational aspects of commercial biopharma manufacturing, such as process automation and single-use equipment.

+ Knowledge of process monitoring tools like PI and SIMCA.

+ Ability to work independently and produce quality results with minimal direction.

+ High energy with the ability to multi-task and handle a fast-paced dynamic work environment.

Work Environment

This is a non-laboratory-based position. The role involves working in a dynamic and fast-paced environment, requiring high energy and the ability to multi-task. The work is collaborative, involving cross-functional teams and interactions with various site functions

Pay and Benefits

The pay range for this position is $23.00 - $27.00/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 Holly Springs,NC.

Application Deadline

This position is anticipated to close on May 2, 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.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.