Peak Bio is a newly created venture out of the San Francisco Bay Area, that will soon reach a critical milestone in our history of going public on NASDAQ.   We are seeking scientific and business talent at two of our critical sites that include our center of research excellence in Palo Alto, California, and our G&A infrastructure in South Florida.   

Peak Bio is a clinical-stage biopharmaceutical company focused on commercializing innovative therapeutics that aim to improve and address significant unmet medical needs for patients with inflammatory, rare and specialty diseases, and cancer. We seek qualified, energetic, and talented individuals with a desire for growth, and advancement but with a knack for working in a cross-cultural, team-based environment.  The talent we seek works well with others and knows that, in the end, the company’s overarching goal is to improve the human health experience and help solve the medical mysteries that challenge us daily.   As a company we will continue to explore, work closely with and partner with external researchers, clinicians, patient advocacy groups, academic institutions, governmental agencies, and our investors to continue to expand treatment options and partnerships to meet those expectations and find novel approaches to treat disease.

 This is a full-time position based in our Palo Alto, California (preferred) or possibly remote with travel required for meetings.

The Director ADC CMC will work closely with Executive Director, Head of Oncology, and other cross-functional professionals to design, develop, and lead the ADC manufacturing strategy for the company, identifying opportunities for compliance process and services for a newly public, clinical, and R&D stage company.  We are looking to expand our process development (PD) team with an experienced PD and conjugation expert who will provide technical expertise, guidance, and leadership to drive PD with an external partner (CDMO) for an Antibody Drug Conjugate (ADC) therapeutic.

Key Responsibilities

• Maintain strong knowledge of GMPs and manage external CDMOs.
• Provide CMC expertise for highly complex projects/ products (phase 1, 2) and overarching related activities
• Strategize key operations and new initiatives in collaboration with contract manufacturers
• Optimization of the manufacturing processes for ADC pipeline compounds including purification of toxin, antibody, and conjugation at an external partner CDMO.
• Oversee the design and scale-up activities of toxin and antibody purification processes and ADC conjugation
• Work closely with individuals / groups within Peak Bio’s team and CDMOs to solve challenging CMC-related problems. Perform critical data review and provide directions for troubleshooting and investigation.
• Provide on-site presence to support technology transfer and manufacturing as needed
• Review and approve technical documentation including protocols, master batch records, and reports relating to engineering and GMP runs.
• Lead quality investigations and data analysis to address deviations/ non-conformance and implement change controls to ensure timely/ prompt release of batches
• Maintain a good working relationship with CDMO partner(s) to ensure timely and high-quality delivery of product.
• Prepare and review summary tables of data from research and manufacturing reports and author sections of regulatory submission.
• Work closely with regulatory in preparation/ co-authoring regulatory filings (INDs/ CTAs)

Desired Abilities and Qualifications

• M.S. or Ph.D., PharmD, or equivalent Degree in Chemistry, Biotechnology, or related sciences
• 5+ years’ experience working with CMC project and regulatory management
• Experience working with protein therapeutics, antibodies and/or ADCs
• Experience with process development, analytical characterization, process scale-up, and/ or regulatory descriptions of manufacturing processes/ registration of drug substances or drug products
• Experience with project management with external CDMOs for drug substance and drug product
• Prior experience with purification techniques and protein conjugation
• Experience with GxP/ GMP production
• Familiarity with quality by design, late-stage PD and process characterization preferred.
• Advanced interpersonal written and oral communication skills, as well as advanced collaborative skills with an ability to work in a timely manner in a dynamic environment.
• Ability to manage complex projects by exercising independent decision-making and analytical thinking skills
• Ability to work in a cross-functional and international environment, detail-oriented, goal-oriented, quality conscious
• Ability to write and speak English fluently

 In addition, below expertise sets you apart

• Demonstrated track record for successful Health Authority interactions related to CMC submissions
• Can lead global CMC regulatory strategy
• Experience/ working knowledge of EU and US guidelines and regulatory processes for IND
• Provide expert interpretation of applicable EMA/ FDA/ ICH/ Global regulations to ensure CMC compliance
• Manage the preparation and review of complex global regulatory packages
• Oversee global submissions and ensure that the compilation and transmission of submissions are within the global regulatory submissions for consistency and quality across regions, including detailed input on eCTD Module 3 documents for clinical trial and registration filings.

What you will enjoy while working with us

(Any or all of these benefits are subject to change at any time at Peak Bio’s discretion).

• Competitive Pay
• Bonus Eligibility
• Stock Option Eligibility
• Health Care Plan
  • Medical
  • Dental
  • Vision
• 401(k) Plan
• Family Leave (Maternity, Paternity)
• Life Insurance
• Long- and Short-Term Disability
• Generous PTO Policy
• Paid Company Holidays

Does Peak Bio’s mission and unique business model ignite your passion and interest?  Does the opportunity to work alongside talented and welcoming team members make you want to join?  Do the responsibilities and qualifications translate very similarly to what you have to offer?  Does the overall benefits package make you feel valued and appreciated?  If you answer “yes” to these questions, we want you to apply.

Job candidates should be aware that full vaccination against COVID-19 is required as a condition of employment subject to legally required exceptions. Peak Bio is an equal opportunity employer and encourages potential or current employees to request a reasonable accommodation under federal, state, and local regulations, should one be needed.

Please apply using the following link: https://peakbio.bamboohr.com/jobs/view.php?id=68&source=aWQ9MTE%3D