Associate Director, Process Engineer

Heron Therapeutics develops cutting-edge medicine to meet unmet patient needs and solve big problems by applying our innovative science and technologies with well-known pharmacology. With therapeutic areas in Oncology and Acute Care, our goal is to offer alternatives so patients can be opioid-free post-surgery. With additional products and indications on their way, we are excited to be growing and adding to our amazing team.

Our entrepreneurial culture gives everyone the chance to be heard with easy access to decision-makers like other smaller companies, along with some of the sophistication and benefits of larger organizations. We developed the Heron Ways of Working to implement training and practices that breathe life into our values and embed them into our daily experience such as open collaboration across teams, self-responsibility & accountability, communication strategies & techniques, and the mindset of always assuming positive intent!

The primary duties will involve the management of drug product manufacturing activities at contract manufacturing organizations (CMOs). The successful candidate should have expertise in parenteral process manufacturing, aseptic process validation, technology transfer, process development, change management and an ability to coordinate multiple projects CMO locations.

This position is remote but needs to be located near one of the CMOs in Minneapolis, MN.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Direct, oversee, or develop processes at CMOs in support of clinical phase programs through commercial production. Act as company liaison, person in plant, for activities at CMO sites.
• Collaborate with internal Quality Assurance, Quality Control, Regulatory Affairs and Supply Chain teams to align on company product development and production goals. Collaborate with Quality organizations to assure GMP standards are met and execute agreed to Quality performance/improvement deliverables.
• Define development pathway for CMO activities to meet corporate goals. Develop contingencies or risk mitigation strategies and allocate resources as appropriate to ensure project milestones are achieved.
• Author or review process documents as subject matter expert for development reports, process protocols, reports, master batch records and other relevant documents.
• Responsible for manufacturing process development, implementation, and continuous improvement to improve efficiency and consistent process performance. Manage process validations (IQ/OQ/PQ) at CMOs.
• Prepare performance objectives and metrics for supplier and company. Monitor and report on process trends of important performance indicators.
• Deliver frequent verbal and/or written communication for internal meetings and external collaborators.

Requirements:

• Requires a degree in Biology, Pharmacy, Chemistry or Engineering (Chemical or Mechanical): Bachelor's / Master's degree with 10+ years of experience or PhD degree with 8+ years of experience.
• Experience in management of drug product production techniques and processing at CMO sites. Proficiency with sterile and aseptic drug product production in vials and pre-filled syringes is highly desired.
• Strong knowledge and demonstrated practice of ICH/cGMP and relevant ISO guidelines.
• Detail oriented with strong written and oral communication skills, and work with others in a multidisciplinary team environment.
• Ability to troubleshoot problems, work within a team and independently under minimal supervision to design, develop, and execute projects.
• Ability to travel 15-40% within and outside of the USA as required to meet project objectives.

The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.