Sr./Lead Process Development Engineer-Crystallization
Alkermes, Inc. - Waltham, MA

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Company Overview:

Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression.

Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland; Gainesville, Georgia; and Wilmington, Ohio. For more information, please visit Alkermes’ website at Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases.

As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our track record for successful drug development is evident from the more than 20 marketed drugs that use our proprietary technologies, and perhaps most clearly exemplified by the five key commercial products propelling our growth. These are breakthrough products in major disease areas, such as schizophrenia, addiction, and multiple sclerosis.

Position Summary:

Alkermes process development integrates drug substance crystallization and drug product unit operations to develop efficient and robust manufacturing processes that provide high drug product quality. This successful candidate will design, develop, scale-up and optimize drug substance crystallization and drug product unit operations at various scales ranging from R&D to cGMP Phase III manufacture. The individual is expected to show a strong lab presence, design and execute experiments with a focus on process understanding & robustness, interpret data, participate in development teams and write technical reports. The candidate should have strong communication & interpersonal skills, be able to multi-task and have a commitment to continuous learning. A solid background in chemical engineering is required. Responsibilities include but are not limited to:

• Responsible for developing and scaling up batch and continuous crystallization process with a focus on defining key experiments to optimize the processes and identify critical process parameters

• Support the development and scale-up of drug product unit operations with a focus on understanding how drug substance attributes affect final drug product attributes

• Collaborate with Chemical Development to support development of drug substance synthetic operations with a focus on understanding mass/heat transfer changes on scaleup.

• Collaborate with CMC team(s) to define and execute development strategies that enable the successful launch of our drug products.

• Integrate QbD principles into all project activities.

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

Minimum Education & Experience Requirements:

• MS or PhD in Chemical Engineering

• 3+ years crystallization experience for PhD candidates/5+ years crystallization experience for Masters candidates

Knowledge/Skills Needed:

o Proven ability to apply scientific principles to design, execute and interpret experiments

o Statistical design of experiment experience

o Excellent written and oral communication.

o Team player with good interpersonal skills

Desired but not required:

o Solids unit operations experience, such as blending, granulation, compaction, etc.

o Pharmaceutical cGMP manufacturing experience

o Quality be Design experience

o PAT experience

Personal Attributes Needed:

• Motivated self starter

• Positive, adaptable, can-do attitude

• Ability to work independently

• Ability to travel and work flexible hours as required

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

EEO Statement: 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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.