Sr. Director, Process Development Downstream

10 hours ago


Tustin, California, United States Avid Bioservices Full time

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Your Role:

The Sr. Director of Process Development Downstream will be responsible for leading a group of about 18-25 scientists and engineers and managing the day-to-day operations of a critical technical department. The Department is responsible for all technical aspects related to developing purification processes for the manufacture of biological/recombinant proteins expressed in mammalian cells; scale-up and successful tech. transfer of processes to the manufacturing facility. Interacting with clients and their technical teams is an integral part of the responsibilities.

  • Lead and manage a technical team of 18-25 engineers and scientists.
  • Develop purification processes for the manufacture of biologics/recombinant proteins expressed in mammalian cells.
  • Enable successful technology transfers of all relevant information from a client's technical team and from the internal process development team to the manufacturing floor.
  • Ensure successful scale-ups and support the manufacture of batches in the manufacturing suites at Avid.
  • Interact with clients and represent Avid's technical capabilities.
  • Ensure the quality of products is maintained, safety procedures are followed, and company guidelines are adhered to.
  • Proactively identify potential issues or gaps that pose a risk to the development of the manufacturing process, lead initiatives on continuous improvement and propose and execute plans for new technology adoption.
  • Provide technical updates to the senior management team periodically or on an as-needed basis.
  • Maintain a good working relationship with key partners such as the MSAT, manufacturing, quality assurance, supply chain, and other teams.
  • Keep abreast of new and emerging technologies. Develop and propose a plan for the implementation of applicable and relevant technologies.
  • Lead the adoption of lean practices and implement a continuous improvement mindset in partnership with the supporting organizations, to improve quality, delivery, cost, and productivity.
  • Manage day-to-day operations of the department including goal setting, performance management, recruiting, and planning and maintaining a budget.
  • Partner with BD teams to provide technical input for proposals, client meetings, and project scoping. Participate in client presentations and technical due diligence.
  • Mentor and develop technical staff to build a high-performing team.

Minimum Qualifications:

  • Ph.D. (preferred) or MS in a science or engineering discipline with 10-15 years of experience in a Process Development group for pharmaceuticals, preferably biologics.
  • 7-10 years leading technical teams and managing complex downstream process development projects at a pharmaceutical company or a CDMO.

Preferred Qualifications:

  • Ph.D. in a science or engineering discipline.

Position Type/Expected Hours of Work:

This role is a full-time position. The core working days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. However, the incumbent candidate will be expected to work additional hours above and beyond the listed schedule.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $195,000 to $215,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

  • You have a "bring it on" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
  • Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
  • You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
  • You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.



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