Associate Director, Chemical Development and Manufacturing

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Associate Director to join our growing Process Chemistry team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The chemist will be emersed into all aspects of small molecule development from process design to cGMP manufacturing. The role will lead and support activities and act as the Subject Matter Expert to solve technical challenges and develop sustainable processes to provide unhindered drug supply to patients. The chemist will significantly collaborate and grow in this role gaining leadership experience in data driven process development, CDMO management, production, CMC, and regulatory submissions.

What you will do:

• Solve technical issues relating to external drug substance manufacturing by providing technical leadership within the chemical development group
• Responsible for drug substance process design, optimization, scale-up, technology transfer, and validation with a focus on clinical manufacturing; ensure relevant data is captured in reports provided by external CROs/CMOs
• Serve as the drug substance technical lead on a CMC sub-team and project leadership within chemical development and DS project point of contact with CDMOs
• Identify key knowledge gaps and execute plans to ensure our process understanding is commensurate with a given program’s stage of clinical development
  
  

What you bring:

• MS or PhD in organic chemistry or chemical engineering with 10+ years (MS) or 6-10+ years (PhD) of industry experience
• Must have knowledge and understanding of organic chemistry including expert hands-on experience.
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment
• Experience authoring regulatory documentation in support of clinical trials (IND, QOS, IMPD, Briefing Booklets, etc.) and submissions (NDA and MAA).
• Strong verbal, written, and interpersonal communication skills
• Demonstrated proficiency to manage timelines by effective prioritization to timely meet departmental and corporate goals
  
  

Preferred Qualifications

• Experience managing CROs and CMOs
• Experience with and demonstrated application of advanced technologies to enable and accelerate development including flow chemistry, computational modeling, PAT, DOE, and/or process modeling.
• Previously served as a drug substance lead/SME for clinical development programs
• Ability to travel quarterly
  
  

Concerned that you don’t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you’re excited about this role but your previous experience doesn’t align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• The current base salary range for this position is expected to be between $149,069 and $223,604 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
  
  

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.