Director, Manufacturing Sciences and Validation, Technical Operations

Technical Operations San Francisco, California


Description

Position Function:  The Director, Manufacturing Sciences and Validation is accountable for the successful drug substance process characterization, validation and manufacturing of Drug Substance at Apellis’ Contract Manufacturing Organizations.  The individual will be responsible for assuring Drug Substance conforms to regulatory and company standards and satisfies GMP regulations.  The individual will collaborate with internal teams, consultants, development organizations, CMOs, and suppliers to lead this key function for the organization.

Key Responsibilities Include:

  • Develop strategies and standards to establish validation protocols for processes and test methods. Review and approve such protocols
  • Ensure manufacturing processes are validated and maintained in a state of compliance with applicable cGMP and global health regulations
  • Collaborate with cross functional teams to develop robust systems for identifying, challenging, qualifying and trending Critical Process Parameters, Critical Material Quality Attributes and Control Strategies
  • Utilize a risk-based approach to develop and implement effective process control systems to ensure process robustness
  • Use risk management, investigational techniques, root cause analysis and quality concepts in the identification and evaluation of compliance risks
  • Develop, and support a statistical process control approach to ensure process reliability and capability
  • Review and approve batch production records and written instructions to ensure cGMP compliance and maintain current quality standard
  • Review and approve deviations, investigations and CAPAs and make recommendations to Quality Control
  • Review proposed changes to validated processes and test methods via CAPA, change control and work orders to assess risk and identify requirements necessary to maintain a validated state
  • Gather knowledge as the basis for the manufacturing control strategy, the approach for process qualification, process improvements and continuous process verification
  • Review essential elements of scale-up and technology transfer leading to a successful process re-validation and a robust commercialization
  • Direct scientific and technical personnel in designing and writing process optimization and validation protocols. Review and approve protocols, reports, investigations and other technical documentations related to process design, optimization and validation at commercial batch scale
  • Maintain department expertise in process validation and related activities. Act as a Subject Matter Expert in discussion and communication with internal regulatory functions including activities associated regulatory submissions
  • Provide technical direction and guidance to all activities associated with process validation activities. Mentor, train and develop future leaders in process validation and associated disciplines
  • Serve as a scientific and technical resource and mentor in the most current aspects of continuous process validation / verification
  • Keep current with regulatory affairs, compendial requirements, technical innovations and topics of current interest regarding continuous process verification and life cycle management and contribute to alignment and harmonization of local validation practices with global policies
  • Monitor CMO performance. 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
  • Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal departments (R&D, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of corporate objectives associated with process validation, compliance and related activities
  • Assist in conducting CMO audits to ensure quality systems and controls are in place.

Required Experience & Qualifications:

  • Demonstrate SME level knowledge of process validation and life cycle management concepts, standards and GxP regulations. Strong technical experience in the successful management of complex process validation projects is required
  • Proven track records of staff management, team development and management experience
  • Knowledge in optimization, manufacture and analysis of peptides and peptide related substances is desirable
  • Demonstrated ability to lead people and get results through others
  • Ability to communicate effectively and document scientific and technical studies and associated results.
  • Ability to lead and drive others for results
  • Knowledge of pharmaceutical processes and systems along with significant development, scale-up, validation and manufacturing
  • Excellent writing skills. Excellent technical computer skills, communication, comprehension, interpretation, problem solving, team spirit, critical thinking and organization skills
  • Degree in life sciences / engineering or related field
  • proximately 10 years of progressive experience in cGMP development and manufacturing
  • Must have valid passport

Working Conditions: May require travel to Company’s CMOs to oversee the virtual development and manufacturing network (estimated at 25%).

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 pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

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.