External Manufacturing Lead

Employer
Attralus
Location
Working from home
Posted
Jul 22, 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 Process Development/Manufacturing expert to lead critical activities within the CMC function. Reporting to the Senior Vice President, Head of CMC, the External Manufacturing Lead will provide guidance and oversight for all aspects of CMC development and cGMP activities at contract development and manufacturing organizations (CDMOs). This includes ensuring adherence to technical plans, project timelines and budget at CDMO sites for timely and uninterrupted supply of clinical trial material. The External Manufacturing Lead will work both independently and with cross-functional teams to provide high-quality support of multiple therapeutic projects. The position will function remotely, with occasional travel to Attralus’ San Francisco Bay Area home office, along with onsite work at CDMOs as appropriate and safe.

ROLES, RESPONSIBILITIES & EXPECTATIONS

  • Provides scientific expertise to design and implement innovative yet efficient solutions for the development of novel therapeutics, solving challenges and ensuring that project deliverables meet aggressive timelines
  • Coordinates product development and manufacturing activities, including, but not limited to: issuing requests for proposals for production and analytical services; participating in review and approval of contracts, work orders and change orders; supporting design and scheduling of CMC development activities and cGMP manufacturing campaigns for Drug Substance and Drug Product
  • Serves as a scientific/technical point of contact to CDMOs regarding some or all of the following: cell line development, cell culture and purification process development, formulation and drug product development, analytical method development, product and impurities characterization, cGMP manufacturing and testing, batch record review, deviation investigation, and stability studies
  • Manages relationships with contract facilities and suppliers, including communication and technical oversight, to meet accelerated timelines and to ensure timely delivery of materials to support IND-enabling studies and activities
  • Serves as an author on regulatory filings and external communications as a subject matter expert on Drug Substance development and cGMP
  • Collaborates with CMC teammates to oversee pre-clinical and clinical supply chain, including inventory and distribution of samples, reagents, intermediates and finished products
  • Ensures product integrity through diligent assessment of cGMP compliance
  • Facilitates technology transfer between contract organizations and sites when appropriate to satisfy project goals and objectives
  • Travels to contract facilities or business partners, both domestic and international, as required
  • Works on cross-functional teams to ensure effective communication between Attralus and its CDMOs and suppliers, and keeps internal stakeholders appropriately informed with CMC activities
  • Supports adherence to budgets, project plans, and performance requirements

REQUIREMENTS/QUALIFICATIONS

  • Bachelor's degree or higher in a scientific discipline, with a minimum of 8+ years of experience in the biotechnology or pharmaceutical industry
  • Expertise in recombinant protein drug substance process development and cGMP manufacturing, with exposure to CDMO management, is required
  • Experience with technology transfer and providing oversight to CDMOs is highly desirable
  • Experience with drug product process development and cGMP manufacturing is a plus
  • Previous authorship of CMC sections of regulatory filings associated with therapeutic proteins is essential
  • Strong understanding of cGMP, FDA and EMA guidance, ICH guidelines, and CMC content of regulatory submissions is highly desirable
  • Experience in drafting requests for proposals, review of work orders and change orders, and maintenance of budgets for manufacturing and analytical services 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, are also essential
  • Project management and/or team leadership experience is a plus

Send your resume and cover letter.