Manager/Senior Manager, CMC Data and Document Management

Employer
Attralus
Location
Remote - Prefer West Coast
Posted
Sep 27, 2021
Required Education
Bachelors Degree
Position Type
Full time

Attralus is a newly established biotechnology company with novel protein therapeutics directed at systemic amyloidosis, which is responsible for a wide range of disease states that are currently underserved by currently available drugs. To meet our strategy of rapidly advancing our novel products into clinical trials and beyond, we seek the services of a Data/Document Management expert to support the CMC function. Reporting to the Senior Vice President, Head of CMC, the Manager/Sr. Manager of CMC Data and Document Management will be responsible for establishing systems and formats for storage and accessibility of all CMC data and documentation generated on behalf of Attralus, and for maintaining the data and documents for its various uses, including but not limited to regulatory filings, materials distribution and implementation, batch disposition, and expiry setting and extension. These data and documents will be associated with both GMP and non-GMP production, which may be sourced from both internal collaborators and contract service providers. The Manager/Sr. Manager of CMC Data and Document Management will also be responsible for maintaining and optimizing Attralus’ internal CMC/GMP documentation system, which will be critical to the company’s operations as it expands in the future. The Manager/Sr. Manager of Data and Document Management will work both independently and with cross-functional teams to provide high-quality support of multiple projects. The position will function remotely, with limited travel to Attralus’ San Francisco Bay Area home office as appropriate and safe.

ROLES, RESPONSIBILITIES & EXPECTATIONS

  • Provides technical expertise to design and implement efficient solutions for the management and use of data in support of the development of novel therapeutics, ensuring that project deliverables meet aggressive timelines
  • Manages Attralus' internal documentation system associated with CMC development and GMP activities, and is responsible for updating and revising the system to meet the needs of the company as it expands
  • Serves as a technical point of contact with contract service providers regarding the transfer of data associated with CMC development (process, analytical, and formulation), pilot and cGMP manufacturing and testing, product specification setting, and stability data analysis
  • Establishes effective relationships with contract facilities and suppliers to ensure timely transfer and delivery of CMC/GMP data and documentation to support internal project updates, regulatory filings, and other external facing activities
  • Provides documentation as required to support product expiry, including extensions, for GMP and non-clinical materials, reference standards, and critical reagents
  • Provides input on generation of new or revised documentation, including authorship of documents as appropriate
  • Supports the authorship of regulatory filings and external communications as a subject matter expert on data management and presentation
  • Collaborates with CMC teammates to support non-clinical and clinical supply chains, including inventory, expiry-setting, and distribution of samples, reagents, intermediates, reference standards and finished products
  • Works on cross-functional teams to ensure effective transfer of CMC data between Attralus and its contract service providers and suppliers, helping to keep internal stakeholders appropriately informed of critical results from CMC activities

REQUIREMENTS/QUALIFICATIONS

  • Bachelor's degree or higher, with a minimum of 5 years of experience in the biotechnology or pharmaceutical industry
  • Experience in management of scientific data, including the establishment and/or maintenance of data management systems, is essential
  • Experience in the establishment and/or maintenance of technical documentation systems is desirable
  • Experience with data assessment in support of CMC development, cGMP manufacturing, or product stability is highly desirable
  • Experience in pharmaceutical drug substance and/or drug product CMC development and cGMP manufacturing/testing is highly desirable
  • Previous support of the authorship of CMC sections of regulatory filings associated with medical products is desirable, with experience in direct authorship being a plus
  • Experience in collaborating with contract service providers is a plus
  • Familiarity with cGMP, FDA and EMA guidance, ICH guidelines, and CMC content of regulatory submissions is desirable
  • Excellent written and verbal communications skills, both internal and external, are essential
  • Excellence in teamwork, including both remote and face-to-face interactions, is also essential