Technical Writing Director jobs in Philadelphia, PA

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA™ platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET™ (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA™ platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work®

About the position

Reporting to: Senior Director, CMC Regulatory Affairs, The Manager/Sr. Manager, Technical Writing – CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs plays a critical role in ensuring compliance with regulatory requirements pertaining to drug development and manufacturing processes. The Manager/Sr. Manager, Technical Writing for CMC will interface with clinical, nonclinical and CMC personnel in the production of high-quality documentation that is appropriate for its intended audience (e.g. regulators, tech transfer recipients, internal scientists/engineers). The Manager/Sr. Manager will work with Technical, Quality and Regulatory personnel to ensure compliance with US, EU, and ICH requirements. This position requires a combination of strong technical writing capabilities, regulatory expertise, project management skills, and collaboration with cross-functional teams to achieve regulatory milestones and support the company's overall vision of bringing accessible cures for patients with autoimmune diseases.

Responsibilities:

• Authors, reviews, and assists with submission of CMC documentation for INDs, IMPDs, BLAs and MAAs for cell and gene therapy programs.
• Authors, reviews, and assists with completion of technical documentation to support CMC Technical organization (e.g. technical transfer documentation, regulatory request for information, etc.).
• Manages document preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones, and document deliverables.
• Ensures accuracy, completeness, and compliance of regulatory submissions with regulatory requirements and company standards.

• Participates in CMC change controls to ensure released products are manufactured in agreement with established regulatory submissions and regulatory guidance.
• Works with technical teams to convert technical data and results into reports in support of regulatory submissions.

• Reviews and edits documents including those authored by others both internally and externally.
• Is a collaborative team player participating in both internal and external project team meetings as needed and offers proactive solutions and advice to team members.

• Remains compliant with company training, and authors and/or reviews departmental (CMC and regulatory) SOPs as needed.
• Identifies opportunities for process improvements and efficiency enhancements in CMC-related activities.
• Implement best practices and lessons learned to optimize regulatory processes and streamline project execution.
• Performs other activities as assigned.

Qualifications:

• Degree in Biological Sciences, Chemistry, Chemical Engineer or equivalent;
• Senior Manager: BS or MS with 6 years’ experience or Ph.D. and 2 years’ experience in a technical writing capacity
• Manager: BS or MS with 3-5 years’ experience or Ph.D. and 0 years’ experience in a technical writing capacity
• Familiarity with the key regulatory requirements and guidelines for drug development and manufacturing, including FDA, EMA, and ICH guidelines.
• Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IMPD, INDs, MAAs, NDAs, and BLAs, is preferred.
• Ability to critically analyze, synthesize, and present complex information in well-constructed documents.
• Working knowledge of drug/biologics CMC development, data analysis, and tech transfer.
• Ability to support multiple projects and to prioritize work independently.
• Ability to comply with company and/or industry style guides and templates.
• Ability to guide and train others in the writing of technical documentation.
• Ability to work effectively in a cross-functional team environment.
• Fluent written and spoken English with excellent attention to detail relative to consistency, grammar, syntax, and scientific accuracy.
• Advanced MS Skills in Word, Excel, Powerpoint, Viso and Adobe Pro
• Confidence to present to management, peers, and scientific or business collaborators.
• Strong written and verbal communication skills.
• Strong team orientation and passion for continuous self-development.
• Experience in the biotech industry or in a startup industrial setting is preferred.

Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.