Associate Director, Packaging Engineering

Technical Operations San Francisco, California


Description

Position Description:  

The Associate Director, Packaging Engineering will be responsible for the design, development, testing, coordination, and implementation of primary, secondary, and tertiary global packaging solutions for clinical and commercial parenteral drug products. The position will support packaging projects at contract packaging organizations, manage packaging component suppliers, and ensure uninterrupted supply of product to patients.

 Key Responsibilities Include:

  • Lead packaging design and development activities including generation of user requirements, identification of packaging design, and research and selection of packaging materials, suppliers, and technologies.
  • Design and facilitate execution of packaging study protocols such as shipping qualifications, transportation studies, and label adhesion studies.
  • Create technical documentation such as packaging specifications, technical drawings, and qualification or validation protocols and reports.
  • Author or support assessments for comparability, manufacturability, suitability and risk assessments.
  • Identify new packaging suppliers and CPOs as needed, and participate in qualifications and compliance audits as required.
  • Actively manage external development and packaging activities, ensuring close partnership through open and transparent communication, scientific and strategic understanding, and attention to priorities and details.
  • Establish effective relationships with development and manufacturing/packaging partners to provide oversight and coordinate with internal teams.
  • Review packaging records and written instructions to ensure cGMP compliance and maintain current quality standard.
  • Review deviations, investigations and CAPAs and make recommendations to Quality Assurance.
  • Monitor Contract Packaging Organization (CPO) Communicate findings, including risks and opportunities to internal stakeholders during project meetings and trigger corrective actions.
  • Participate in various cross-functional projects as needed and appropriate.
  • Other duties as required.

Required Experience & Qualifications:

  • Degree in packaging engineering, mechanical engineering, biomedical engineering, chemical engineering, or related field
  • 10+ years packaging related experience with 5+ years of experience in the pharmaceutical, biotechnology, medical device, or health care industry.
  • Strong technical skills and knowledge of packaging components including primary, secondary and tertiary packaging.
  • Experience collaborating with external suppliers, CPOs, or contract test laboratories.
  • Understanding of the serialization process and its implementation in the pharmaceutical industry.
  • Experience working with packaging artwork a plus.
  • Knowledge of packaging related standards and regulations.
  • The ideal candidate has passion for learning, creating, relating, communicating, and working in cross functional teams.

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%).

About Apellis: Apellis is 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.