Looking for an inspirational career? Be a revolutionary.
We’re dedicated to developing new antibiotics that will address critical health problems now and in the future. We hope you share this vision, and will bring your talent and ideas to this important goal. Our groundbreaking technology provides the opportunity for rapid development of important new drugs. Come join us and help us move forward: Every minute counts. Come join a small, highly focused team in the Boston area. Please use the form below to inquire about employment opportunities.
Benefits and Rewards
Macrolide Pharma’s offers benefits to attract and retain the most talented individuals with skills and energy to contribute to our shared vision of building a collaborative drug development company. We offer competitive health and financial compensation and benefits packages that reward employees with a share in our company’s success.
Health, wellness and financial benefits
We provide a comprehensive benefits package aimed at improving the financial, physical, and personal health of our employees and their families. Here are some of our benefits:
- Health care coverage, including medical, prescription drug, vision, dental
- Life and disability insurance
- 401(k) plan with a competitive company match
Paid time off
We believe supporting a positive work-life balance is crucial for employee satisfaction and performance — we encourage our employees to spend ample time with family and friends. We offer substantial paid time off and paid holidays each year.
Macrolide Pharmaceuticals is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Macrolide Pharmaceuticals also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Associate Director of Analytical Chemistry
We are seeking a motivated and versatile individual to join our CMC group as an Associate Director of Analytical Chemistry. The successful candidate will support early-stage programs within our development portfolio. S/He will be responsible for developing phase appropriate analytical methods for our small molecule programs, transferring these methods to CROs/CMOs, and for directing analytical development and validation at CROs/CMOs. This position will be responsible for support of non-GMP and GMP manufacturing, stability studies, and release testing for both drug substance and drug product and will work closely with other CMC functional areas, the Quality unit, and outside contractors. The candidate should have extensive experience in drug development and in collaborating with internal and external groups. The candidate should be innovative, reliable, flexible, and have a proven track record of solving complex analytical problems as well as the ability to work effectively in a team environment. This individual will interact with colleagues in CMC, discovery chemistry, pre-clinical safety, and clinical groups. This position will report to the Executive Director of CMC.
Some domestic and international travel is required.
• Establish and direct analytical activities for GMP and non-GMP manufacture of drug substance (DS) and drug product (DP) that will include method development and transfer, in-process testing, raw material testing, method validation, DS and DP release testing, stability studies, reference standard characterization, etc.
• Responsible for stability programs and providing recommendations on shelf life and storage conditions.
• Develop and execute chemical and instrumental methods (e.g., HPLC, GC, IC, MS, FTIR, TGA, DSC, XRPD, DVS, KF, ICP-MS, etc.).
• Manage- 3rd party development of analytical methods, method validation, and investigations for out of specification, out of trend, and/or anomalous results.
• Collaboratively plan and execute cross-functional studies for chemical development and formulation development.
• Responsible for representing analytical activity across multiple functional groups including CMC team.
• Provide scientific leadership in the generation of validation reports, regulatory documents, investigations, and risk assessments.
• Write, review, and approve cGMP documentation (SOPs, protocols, technical reports, specifications, etc.).
• Troubleshooting and resolution of technical and compliance issues at CRO/CMO. Analyze and interpret data.
• Appropriately apply the cGMP between regulated and non-regulated activities.
• Recognize and respond to unexpected or anomalous observations in all activities.
• Maintain complete and accurate records in conformance with company SOPs and training.
• Provide detailed reviews of data generated from contracted service providers.
• Work with internal and external audiences to meet agreed-upon milestones within established time and budget targets.
• Contribute to relevant sections of domestic and international regulatory filings.
• Travel, when necessary, to 3rd party manufacturing and/or testing sites.
• A Ph.D./MS (Ph.D. preferred) in a relevant scientific discipline (analytical and organic chemistry preferred) and 6 + (Ph.D.) or 10+ (MS) years of experience in the pharmaceutical/Biotech industry.
• The candidate must have strong knowledge of analytical chemistry, pharmaceutical analysis, extensive experience with chromatography and other core analytical techniques, an understanding of phase driven drug development, cGMP and be familiar with guidelines and policies from a variety of organizations (FDA, EMA, ICH, etc.) and the overall regulatory environment’s expectations for CMC.
• Prior experience in the development of challenging analytical impurity methods, including HPLC/UPLC coupled with various detectors (UV, Mass, CAD, and ELSD, etc.), is a must.
• Proven track record and established leadership in analytics applied to clinical drug development and GMP manufacture.
• Prior CRO/CMO management is essential. Significant practical experience conducting method transfer, both as the originating and receiving site.
• Significant experience in evaluating analytical data and drawing meaningful conclusions. Ability and willingness to make independent decisions in areas of responsibility.
• Detail oriented and strong written and verbal communication skills.
• Prior experience in contributing to both domestic and overseas CMC regulatory filings of all types.
• Experience working in a timeline driven setting.
What makes us different?
We use chemistry to create antibiotics that have never been seen before.