Director, Biologics CMC Technical Writing - Remote
Travere Therapeutics
Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead authoring of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. You will coordinate cross-functional teams and drive regulator-ready narratives that communicate development history, manufacturing, and control strategy. The role requires extensive biologics expertise, strong writing skills, and the ability to influence SMEs, Regulatory Affairs, and QA across San #J-18808-Ljbffr
$189 per hour
...positions listed as San Diego/Remote, our preference is for candidates... ...Stock Units) Department - Technical OperationsBe a part of a global... ...patients.Position Summary:The Director, Technical Operations (Biologics CMC Technical Writing) is responsible for the preparation...Remote workContract workWork experience placementWork at officeLocal area2 days per week- ...Scorpion Therapeutics seeks a Director of Biologics CMC Technical Writing to lead the creation of Chemistry, Manufacturing, and Controls documentation... ...-functional teams through reviews and approvals while remote work with roughly 10% travel. This role demands deep...Remote work
- ...Travere Therapeutics in San Diego, remote-friendly, seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead CTD Module 2/Module 3 content for regulatory submissions. You will collaborate with Regulatory Affairs, SME teams, and external partners...Remote work
- ...Travere Therapeutics, a biotechnology company focused on rare diseases, seeks a Director, Technical Operations (Biologics CMC Technical Writing) in San Diego with extensive CTD Module 2/3 experience. The role leads CMC submission strategy, collaborates with Regulatory...Remote work
- ...Scorpion Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead regulatory writing for biologics. You will develop submission... ...-functional teams including external partners. Remote role with some onsite requirements in San Diego;...Remote work
- ...Travere Therapeutics is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CTD Module 2 and 3 content for regulatory submissions, including BLA. The role requires strong scientific judgment, superb writing, and collaboration...Remote work
- ...Travere Therapeutics, located in San Diego with remote flexibility, seeks a Director of Technical Operations (Biologics CMC Technical Writing). You will lead the preparation of CTD Module 2/3 for regulatory submissions, coordinating with Regulatory Affairs, QA, Manufacturing...Remote work
- Travere Therapeutics seeks a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions, including BLA. The role oversees content integration, timelines, and regulatory messaging across multiple...Remote job
- Director of Technical Operations (Biologics CMC Technical Writing) Responsibilities: develop and execute CMC submission strategies author and coordinate Module 3 content... ...experience international travel (~10%) Location: Remote (San Diego-based, with some onsite requirements)....Remote work
- Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of CMC documentation for regulatory submissions, including BLA. You will guide the strategy in collaboration with Regulatory Affairs and SMEs, directing...
- ...Senior Director, Biologics CMC (4 days onsite, 1 day remote) Position Summary Reporting to the Head of CMC, the Senior Director, Biologics CMC will... ...development. This individual will possess deep technical expertise in cell line development (CLD), upstream...Remote workFull time
$160k - $274k
Job Title - Senior Director, Mid-Atlantic CMC Work Location - United States (Remote) Summary: Opportunity for... ...with the client, technical team, and business development... ...and promoting WuXi Biologic’s services at... ...areas. Experience in writing regulatory documents and...Remote workWork from homeFlexible hours- ...process. Associate Director, Manufacturing Development... ..., and Controls (CMC) project management activities... ...as a key partner to Technical Operations, Process Development... ...understanding of biologics manufacturing and CMC... ...time in the office, and remote employees are expected...Remote workFull timeContract workWork at officeLocal area
$150k - $200k
...Role The Head of Technical Solutions sits at the... ...Brooklyn, NY office. Remote considered only for exceptional... ..., translating CREW’s biological treatment technology... ...accounts — utility directors, chief engineers,... ...Exceptional technical writing skills, with the ability...Remote workFull timeWork at officeFlexible hours- ## Associate Director, Regulatory Affairs CMCApplyremote... ...As the Regulatory CMC lead for these... ...* Assess proposed technical changes and... ...biochemistry, chemistry, biology, or related... ...communicate verbally and in writing, and superb... ...that balances remote work flexibility with...Remote workContract work
- ...looking for someone to own CMC for it end to end, from... ...to IND. This is a director-level role: hands-on... ...at least 12 years in biologics CMC. At least 1 antibody... ...CDMOs, including writing the RFP and reading the... ...there is 1 program today. Remote is fine and we have no...Remote workPermanent employmentFull timeContract workInterim role
- ...Scorpion Therapeutics is seeking a Senior CMC Director to lead the development and execution of CMC strategies for small molecule programs... ...regulatory filings and ensuring compliance. You will provide technical leadership, mentorship, and author regulatory documentation,...Remote work
$150k - $210k
...Leveraging our expertise in muscle biology and small molecule drug... ...position will contribute regulatory CMC experience to Edgewise... ...options. Contributes to the writing, editing, reviewing and compiling... ...with experience working in a remote environment. ~ Able to...Remote workFull timeFor contractors$108.4k - $146.4k
...This Opportunity WSP is currently seeking a Senior Technical Manager, Biology to join the team in New York at either our Buffalo, Syracuse... .... Actively engage in business development and proposal writing. Fully-developed state-of-the-practice and state-of-the...Work at officeLocal area$150k - $195k
Department:106800 Technical OperationsLocation:San Diego, USA- RemoteBe a part... ....Position Summary:The Associate Director, Technical Operations (Small Molecule CMC) will provide technical oversight... .... No role is expected to be 100% remote.Travere is an EEO/AA/Veteran/...Remote workFull timeContract workTemporary work- ...Travere Therapeutics in San Diego, CA is seeking a Director of Technical Operations (Biologics CMC Technical Writing) to lead CMC documentation for regulatory submissions. The role emphasizes drafting Module 3 sections, writing drug substance/product manufacturing content...Remote work
- ...Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead authoring of CTD Module 2 and Module 3 content for regulatory submissions, including BLA. This role partners with Regulatory Affairs, SME, Quality, Manufacturing,...Remote work
$160k - $175k
...Position SummaryCerus is seeking an experienced Technical Operations Manager with expertise across Chemistry, Manufacturing, and Controls (CMC) activities supporting commercial and... ...project teams.Excellent technical writing, communication, and project management skills...Contract workTemporary workWork at officeFlexible hours- ...We’re looking for a Technical Proposal Manager to join... ...team in a US-based, fully remote role. You’ll be the technical... ...side by side with our Director of Business Development for Biologics & Biomarkers, our... ...your bioanalytical and writing expertise to work? Apply...Remote workFull timeWork at office
$139k - $232k
...hands. Summary Of Role We are seeking an Associate Director, Technical & CMC Support (PET Quality Operations) to provide strategic and... ...reliable supply, and advance continuous improvement. This is a remote position open to applicants authorized to work for any...Remote workContract workWork at officeLocal area$211.41k - $286.02k
...role, as a Scientific Director, Product Stewardship Toxicology... ...is hybrid, option for remote work may be available.... ....Product Quality & CMC ToxicologyLead... ...supporting ISO 10993 biological evaluations.Lead toxicological... ....Excellent scientific writing, technical communication and...Remote workFull timeFlexible hours- ...General Information Name: Associate Director, Regulatory Affairs - CMC Ref #: 15322 Posting Date:... ...2026 Work Schedule: Full time Remote Work: In office Job: RI - R&D,... ...CMC lead will collect technical data from relevant partners to write regulatory CMC documents and support...Remote workPermanent employmentFull timeTemporary workWork at office
- ...Vice President / Senior Director, CMC & Technical Operations About Contraline Contraline is a clinical-stage biotechnology company focused... ...manufacturing, and regulatory interactions. ~ Hands-on experience writing, preparing, reviewing, or defending CMC content for...
$210k - $265k
...amyloidosis (ATTR). About the job The Director, Medical Writing is responsible for authoring,... ...investigator brochures (IBs), Common Technical Document (CTD) sections, briefing... ...the San Diego region will operate in a remote work model as specified by the company...Remote workFull timeWork at officeRelocation packageMonday to Friday$200k - $275k
...transformative team.POSITION TITLE: Director or Senior Director, CMC Protein BiologicsPOSITION SUMMARY:Calibr... ...and Controls (CMC) strategy for our biologics portfolio, with a particular focus... ...for guiding CMC strategy and technical execution across multiple biologics...Full timeFlexible hours
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