CMC Project Manager, Technical Operations

Technical Operations San Francisco, California


Description

Position Summary:
 
Apellis is a clinical-stage biopharmaceutical company that is focused on developing peptides designed to broadly inhibit complement C3, a central element of the complement cascade, an integral part of the immune system. The CMC Project Manager– Technical Operations is a key member of our team and will play a critical role in helping to manage a cross functional effort to NDA submission. The position will collaborate with internal teams, consultants, development organizations, CMOs, and suppliers to lead this key function for the organization.

Key Responsibilities Include:

  • Guide the team through the development of the CMC global strategic plan that lays out a pathway for the successful development and approval of a new drug candidate
  • Drive the development and manage the execution of high quality, integrated cross-functional plans
  • Apply project management best practices in the development, initiation, planning, execution, control and closing of projects. Provide clear direction on project requirements to meet expectations of external customers and business stakeholders
  • Interact with research and development, marketing, manufacturing, and regulatory departments and with external stakeholders
  • Responsible for project performance, risk management, administration, and issue resolution for team

Education:

  • Degree in life sciences / engineering or related field

Required Experience & Qualifications:

  • Approximately 5 years of progressive experience in cGMP development and manufacturing, including at least 2 years in a project management role
  • Significant experience within the pharmaceutical industry, and strong understanding of all aspects of drug development, Regulatory and CMC specifically
  • The ideal candidate has passion for learning, creating, relating, communicating, and leading cross functional teams
  • Excellent oral and written communication skills, including presentation and meeting facilitation
  • Ability to work independently and with flexibility to handle work flow in a fast-paced and dynamic environment
  • Excellent project management skills and ability to effectively juggle multiple ongoing projects to meet deadlines
  • Must have valid passport

Working Conditions: Will work from the Company’s San Francisco Bay Area office, with additional travel as required to oversee the virtual development and manufacturing network (estimated at 25%).

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.



EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.