OncoMyx Therapeutics is advancing oncolytic immunotherapies with the goal of achieving the greatest therapeutic benefit for more cancer patients. We will improve the effectiveness of therapies and expand their ability to help more cancer patients. To advance the next generation of oncolytic immunotherapies, we have a top team with decades of experience in developing targeted cancer treatments, immunotherapies, and virotherapies who have successfully brought new drugs to market. We are seeking a Director of Technical Operations to lead the day-to-day operations of OncoMyx’s TechOps team while partnering closely with CMOs to development the company’s products. The right individual will actively embrace our unique team-centered culture of innovation, teamwork, trust, balance, and perseverance.
Essential Duties and Responsibilities
Qualified candidates will possess the following skills and experience.
- Establish, lead and direct viral manufacturing
- Partner with technical advisor to hire, provide strategic leadership and mentoring to team members
- Lead and act as the Subject Matter Expert for both internal and external (CMO) tech transfer activities. Direct the translation of research and development programs to GMP manufacturing
- Establish and manage key vendor relationships to support the PD and manufacturing transferred activities. Act as the key point of contact and manage the day-to-day activities of PD and manufacturing programs to ensure project deliverables are achieved internally and externally at the CMO
- Provide regular updates of the internal activities and contracted activities to the cross functional team(s) and management team
- Lead investigation related to process development and manufacturing activities. Author and compile documents related to the investigation. Identify CAPAs and ensure they are executed in a timely manner
- Author, review and approve process transfer document and PD documents to support GMP manufacturing activities
- Author and review relevant documents required to support IND and BLA regulatory submissions
- Review master and executed batch records and all documents related to GMP manufacturing
- Collaborate with internal cross functional teams and collaborators: Represent the manufacturing team in day-to-day cross-functional team forums
- Travels to manufacturing sites and testing laboratories as required
Required Experience, Education, and Competencies
- PhD in pharmaceutics, industry pharmacy, biochemistry, chemical engineering, biomedical engineering, or any equivalent major
- Over 10 years of working experience in biotech or pharmaceutical companies with prior experience in biologics and/or viral vectors formulation and process development
- Experience managing CMOs and outside testing laboratories for various product development and manufacturing activities
- Good knowledge and understanding of cGMP regulations and FDA/ICH guidelines
- Excellent verbal and written communication skills; capable for writing reports and analytical methods
- Team player with ability to positively communicate with team members
- Must be highly organized and able to work independently in a fast-paced environment
- Must be professional, dedicated, detail-oriented, and self-motivated
- Proficiency with word-processing, spreadsheet, chemical drawing, and basic statistical analysis (i.e. MS Word, Excel, ChemDraw, JMP etc.)
- Proven ability to work productively in a virtual/on-site hybrid working environment
Travel Required: Yes, up to 20%
Work authorization/security clearance requirements:
Must be eligible to work in the United States
Please send CV and cover letter by email to email@example.com. No outside recruiters please.
Affirmative Action/EEO statement: OncoMyx Therapeutics is an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.
Other duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.