Job Title: Technical Writer

Job Description

We are seeking a skilled Technical Writer to author and finalize appropriate Module 3 documents and responses to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts. The ideal candidate will have experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, and awareness of ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates.

Responsibilities

• Collaborate with Regulatory CMC and Technical Subject Matter Experts to author and finalize Module 3 documents and responses to Agency Questions.
• Develop and characterize analytical methods for vector and T cell products.
• Ensure compliance with ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates.
• Contribute to pharmaceutical manufacturing processes, aseptic processing, and analytical and process development.
• Support the product lifecycle from product and process development through clinical trials, validation, and regulatory submissions to commercial GMP manufacturing.
• Maintain a thorough knowledge of regulatory requirements for biologics, pharmaceuticals, and medical devices.
• Work collaboratively as part of a team, providing excellent communication and contributing to team-based decisions.
• Think critically and demonstrate troubleshooting and problem-solving skills.
• Accept temporary responsibilities outside of the initial job description as needed.
• Utilize well-developed computer skills and be fluent with Microsoft Office applications.

Essential Skills

• Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry, or equivalent.
• 7 years of relevant experience with a Bachelor's degree, 5 years with a Master's degree, or 3 years with a PhD.
• Experience with CMC/Module 3 regulatory submissions.
• Proficient in high-quality technical writing.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products and aseptic processing.
• Thorough knowledge of biologics analytical and process development.
• Cell therapy process development experience is highly desired.
• Knowledge of product lifecycle, including product and process development, clinical trials, validation, regulatory submissions, and commercial GMP manufacturing.
• Working knowledge of regulatory requirements for biologics, pharmaceuticals, and medical devices.
• Excellent interpersonal, verbal, and written communication skills.

Additional Skills & Qualifications

• Self-motivated and willing to accept temporary responsibilities outside of the initial job description.
• Comfortable in a fast-paced environment with minimal direction.
• Able to adjust workload based on changing priorities.

Work Environment

This position offers a hybrid work environment in Santa Monica, CA. While hybrid work is highly preferred, remote candidates will be considered if they are an ideal fit for the role.

Pay and Benefits

The pay range for this position is $60.00 - $90.00/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 hybrid position in Santa Monica,CA.

Application Deadline

This position is anticipated to close on Apr 7, 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 for other accommodation options.

Salary : $60 - $90