Xeris Pharmaceuticals, Inc. · 2 weeks ago
Director, Formulation Development
Chicago, IL
Full-time
Onsite
Director/Executive
$175K/yr - $250K/yr
10+ years expXeris Pharmaceuticals, Inc. is seeking an experienced Director of Formulation Development to lead and manage a team developing innovative dosage forms and drug delivery systems. This role involves providing strategic and technical leadership across formulation activities while directing complex projects critical to advancing the company’s product pipeline.
BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics
Responsibilities
Lead and manage a team of scientists in the development and execution of complex formulation projects for injectable small molecules, peptides, and proteins using Xeris’ novel proprietary formulation platforms
Provide strategic direction and guidance to the formulation development team on all aspects of injectable small molecule, peptide, and protein formulations, including process development, characterization, scale-up, tech transfer and manufacturing support
Lead high throughput screening of excipients, selection of primary drug container closure systems, identification of degradation pathways, and development of stable formulations
Lead the development and implementation of novel formulation strategies for injectable products, including long-acting formulations, sustained release formulations, and targeted delivery systems
Demonstrate a thorough understanding of relevant technical/scientific literature, standard procedures, and pharmaceutical regulations relevant to the programs
Develop and implement innovative methods for characterization and stability testing of injectable biologics
Drive the development of robust and scalable manufacturing processes for injectable products
Identify and mitigate technical risks associated with formulation development and manufacturing. Anticipate manufacturability challenges associated with parenteral drug product development
Develop and manage project budgets and timelines, ensuring efficient and on-time completion of projects
Communicate effectively with cross-functional teams (e.g., R&D, Regulatory, Manufacturing) to ensure seamless product development
Provide guidance on quality aspects across regulatory filings related to specifications, acceptance criteria, and stability protocols
Cultivate partnerships by serving as lead point of contact with contract manufacturing organizations and external collaborators
Ensure compliance with all relevant regulatory requirements for injectable products, including ICH guidelines and FDA regulations
Contribute to the preparation and submission of regulatory documentation, including INDs, NDAs, and BLAs
Provide expert technical support during regulatory inspections and audits
Build a high performing team through mentoring, goal setting, and supporting the continuing education of junior staff
Contribute to the development of internal training programs and seminars related to formulation science and technology
Write and review study protocols and reports (both formal and informal) to support product development studies and regulatory filings
Stay current with the latest scientific literature and present findings at industry conferences and events
Identify and evaluate emerging technologies and trends in the field of injectable formulation development
Develop and implement strategic initiatives to improve the efficiency and effectiveness of the formulation development process
Qualification
Required
Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering or related discipline
A minimum of 10 years in pharmaceutical development, with increasing management responsibility
Familiarity with regulatory requirements for pharmaceutical development
Passion for innovation and scientific discovery, developing junior staff, and advancing healthcare through novel medicines
Knowledge and proficiency using experimental design and statistical analysis software (e.g., JMP / MiniTab / GraphPad Prism)
Competencies: Attention to Detail, Independent Judgement, Teamwork & Collaboration, Self-Starter, Adaptability, Professionalism, Written & Verbal Communication skills, Functional Leadership, Problem-Solving skills, Project Management skills
Position may require periodic evening and weekend work, as necessary to fulfill obligations
Periodic overnight travel
Must be able to stand for extended periods of time
Must be able to lift 25 lbs. or more
Adequate vision (corrected or uncorrected) to read fine instruments such as instrument displays, etc., and perform visual inspection for defects
This position is based in Xeris' Chicago office and requires five days per week on-site to ensure oversight and leadership of the laboratory team
Position works with potentially hazardous chemicals and active pharmaceutical ingredients
Domestic and/or international travel up to 10% may be required
Benefits
Multiple paid time off benefits
Various health insurance options
Retirement benefits
Commission
Equity
Company
Xeris Pharmaceuticals, Inc.
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
201-500 employees
H1B Sponsorship
Xeris Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$548.5MKey Investors
Hayfin Capital ManagementArmistice CapitalDeerfield
2024-03-06Post Ipo Debt· $200M
2022-01-03Post Ipo Equity· $30M
2021-03-11Post Ipo Equity· $27M
Leadership Team
John Shannon
CEO and Director
Kenneth Johnson
Senior Vice President - Clinical Development, Regulatory Affairs, QA and Medical Affairs
Recent News
2026-01-09
The Motley Fool
2026-01-03
Company data provided by crunchbase