CMC Technical Writer

VARITE INC; United States; Hybrid; USD 103,320 - 117,096; Full time

Job summary

An established industry player is seeking a CMC Technical Writer with expertise in regulatory submissions and technical writing. This role involves authoring critical documents for CMC submissions and collaborating with internal teams to support the development of innovative biopharmaceutical products. The ideal candidate will have extensive experience in analytical method development and a strong understanding of the regulatory landscape. Join a dynamic team in a hybrid work environment, where your contributions will play a vital role in advancing cutting-edge therapies. If you are passionate about making an impact in the biopharmaceutical field, this opportunity is for you.

Qualifications

• 7+ years of relevant experience in CMC technical writing.
• Experience with regulatory submissions and analytical methods.

Responsibilities

• Author Module 3 documents and responses to agency questions.
• Support CMC regulatory submissions and process development teams.

Skills

Technical Writing

Analytical Method Development

Regulatory Submissions

Communication Skills

Problem Solving

Education

Bachelor's Degree in Biochemical Engineering

Master's Degree in Chemical Engineering

PhD in Biomedical Engineering

Tools

Microsoft Office

Job description

This range is provided by VARITE INC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$75.00/hr - $85.00/hr

VARITE is looking for a qualified CMC Technical Writer

WHAT THE CLIENT DOES?

An American biopharmaceutical company that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19.

WHAT WE DO?

Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

Job Title: CMC Technical Writer

Location: Santa Monica, CA - Hybrid/ 100% Remote

Contract Duration: 7 months

Pay Rate: $75 - $85/hr on W2

HERE'S WHAT YOU’LL DO:

Summary:

Seeking a highly motivated individual with late-phase CMC technical experience, including technical and regulatory submission experience. This position is part of the Process Development organization and in this role, this individual will be supporting the internal Process Development teams. In the near-term, this role will support time critical CMC Regulatory submissions. Longer-term, this individual will be embedded in technical teams within the Process Development department supporting CMC aspects of our growing pipeline projects.

Responsibilities (include but are not limited to):

• Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts.
• Experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, awareness of ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates.

Requirements:

• Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experience.
• Experience CMC/Module 3 regulatory submissions.
• Experience in technical writing and proficient in high quality writing.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process development.
• Thorough knowledge of biologics analytical and process development is essential. Cell therapy process development experience is highly desired.
• Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing.
• Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices.
• Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions.
• Ability to think critically, and demonstrated troubleshooting and problem solving skills.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• Well-developed computer skills and fluent with Microsoft office applications.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

If this opportunity interests you, please respond by clicking on EasyApply.

VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Writing/Editing
• Industries: Pharmaceutical Manufacturing and Biotechnology Research