Senior/Principal Engineer, Process Development at Alkermes, Inc. in Waltham, Massachusetts

Job Description:

Senior/Principal Engineer, Small Molecule Drug Substance Process Development

Alkermes Overview

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

Position Summary:

This position will provide technical leadership in the design, scale-up, and optimization of small molecule pharmaceutical crystallization unitoperations at various scales ranging from R&D to cGMP Phase III manufacture. Specific areas of focusinclude crystallization and support for CRO and CMO activities. Strongcollaboration is expected with internal R&D groups, internal commercial partners, and external thirdparty CROs and CMOs. This role is expected to have a strong lab presence, design and execute experiments with afocus on process understanding and robustness, interpret data, participate in development teams and write technical reports. Additional opportunities for applying reaction engineering principles may present based on project needs. A solid background in chemical engineering is required.

Responsibilities include but are not limited to:

• Collaborate within cross-functional teams, specifically with Process Chemistry, Pharmaceutical Chemistry, Formulation Development, Analytical Development, and External Operationsto define, develop, and execute processes for the manufacture of drug substance


• Develop and scale-up drug substance synthesis and crystallization unit operations with a focus onprocess understanding, identification of critical process parameters, and process optimization


• Apply "scale-up/down" approaches to model drug substance unit operations in a laboratory setting


• Design crystallization processes that deliver API/intermediates of desired attributes


• Support technology transfer of drug substance unit operations and production at CMO(s)


• Identify and deploy new technologies as needed


• Integrate Quality Risk Management (QRM) and Quality by Design (QbD) principles into projectactivities in accordance with ICH Q9 & Q11


• Maintain instrumentation and laboratory process equipment


• Write technical reports and deliver presentations to technical, CMC and broader project groups


• Author CMC sections of regulatory filing documents

Senior Engineer Basic Requirements:

• BS in Chemical Engineering with 15+ years of experience


• MS in Chemical Engineering with 10+ years of experience


• PhD in Chemical Engineering with 3+ years of experience

Principal Engineer Basic Requirements:

• BS in Chemical Engineering with 20+ years of experience


• MS in Chemical Engineering with 15+ years of experience


• PhD in Chemical Engineering with 8+ years of experience

Knowledge/Skills Needed:

• Excellent written and oral communication.


• Proven ability to apply scientific principles from first principles to design, execute and interpretexperiments


• Proven expertise in at least one of the following areas: Fundamental Crystallization process development for API & intermediates, includingknowledge of crystallography, version and form screening, solvent selection, etc.


• PAT experience (e.g. ReactIR, Raman, FBRM)


• Skilled in common analytical methods such as PXRD, TGA, DSC, HPLC, FTIR, and UV


• Pharmaceutical cGMP manufacturing experience


• Statistical design of experiments


• Team player with good interpersonal skills

Desired but not required:

• Experience in introducing, implementing and/or executing new chemical processes in pilot orcommercial plants; experience with contract manufacturers is preferred.


• Experience with process modeling software (e.g., Matlab, Dynochem)


• Experience in working with DEA controlled substances


• Quality by Design experience

Personal Attributes Needed:

• Motivated self-starter


• Positive, adaptable, can-do attitude


• Ability to work independently in lab environment a must!


• Ability to mentor scientists at all levels


• Ability to travel (~20%) and work flexible hours as required


• Functional ability to work in a pilot plant and commercial facility

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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Experience Level:
Mid-Senior Level

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