Process Development Engineer I
4 days ago
Job DescriptionThis position designs and executes experimental studies to develop well understood, robust oral solid dosage manufacturing processes. Key duties are process design, equipment set-up, troubleshooting equipment, running experiments, collecting, and evaluating data to identify and implement process/equipment improvements reducing waste and increasing process reliability. Key role in maintaining GMP standards in the pilot facility and manufacturing clinical supplies.Responsibilities: Set up and operation of a new GMP clinical manufacturing suite with a broad range of processing capability and technology approaches. Provide Subject Matter Expert understanding of the operation of processing equipment with ability to assimilate and use new technologies quickly and provide guidance, training, and direction on technical items. Design and select process trains and process flows. Design and execute experiments to enhance process understanding and manufacture GMP batches at various scales. Responsible for the creation of batch records, change controls and standard operating procedures for area of responsibility with a strong focus on efficiency and continuous improvement. Design process development activities focused on developing well understood, science driven products and processes at all scales resulting in robust and repeatable control. Select appropriate parameters for prototype/finished dosage production to ensure product quality and reproducibility are achieved. Preparation of protocols, reports and sections of regulatory submissions. Maintaining compliance with all aspects of cGMP, Safety and Environmental legislation and Company policy, which impacts on day-to-day activities. Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions. Manage, train and mentor junior Process Development staff. Perform other duties as assigned.Basic Requirements: Bachelor's Degree in engineering/scientific discipline, or the equivalent with 5+years of experience in pharmaceutical solid oral dosage processing. Preferred Requirements: Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment. "Hands-on" ability to install and troubleshoot instrumentation and equipment. Subject matter proficiency across a range of processing techniques such as, powder blending granulation, compression, and coating. Demonstrated experience in small molecule process development, scale up and technical transfer. Knowledge of design of experiments, data analysis and data interpretation for process development studies. Technical problem-solving ability utilizing current research and technologies. Understanding of the drug development process and the role and impact of process development within this process. Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills. Understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development. Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities. Previous experience with Process Analytical Technology and drug product formulation is preferred.#LI-HB1About UsAlkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.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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Process Engineer I
1 month ago
Watertown, United States DPS Group Global Full timeSummary A Process Engineer is responsible for ensuring operability and reliability of GMP manufacturing process equipment located at manufacturing facilities. This Candidate provides process engineering service support and coordinate various engineering activities with outside groups (e.g., Manufacturing, Facilities, Validation, Quality). This individual...
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Process Engineer I
4 weeks ago
Watertown, United States DPS Group Global Full timeSummary A Process Engineer is responsible for ensuring operability and reliability of GMP manufacturing process equipment located at manufacturing facilities. This Candidate provides process engineering service support and coordinate various engineering activities with outside groups (e.g., Manufacturing, Facilities, Validation, Quality). This individual...
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Process Development Engineer
4 weeks ago
Watertown, United States LASE Innovation Inc. Full timeWe are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Development Engineer. LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex biological problems and diseases by providing access to high-dimensional...
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Process Development Engineer
4 weeks ago
Watertown, United States LASE Innovation Inc. Full timeWe are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Development Engineer. LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex biological problems and diseases by providing access to high-dimensional...
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Process Development Manager
2 months ago
Watertown, United States Alkermes Full timeJob Description The Process Development Manager manages the pilot scale process development facility and personnel and provides technical guidance for small molecule process development, scale-up and technical transfer of developed processes to manufacturing. The successful candidate will thrive in a highly collaborative matrix team environment to drive...
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Process Development Manager
2 weeks ago
Watertown, United States Alkermes Full timeJob Description The Process Development Manager manages the pilot scale process development facility and personnel and provides technical guidance for small molecule process development, scale-up and technical transfer of developed processes to manufacturing. The successful candidate will thrive in a highly collaborative matrix team environment to drive...
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Director, Process Development
4 weeks ago
Watertown, United States Alkermes Full timeJob Description An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development leadership team with responsibility for process development activities within the business, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This...
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Director, Process Development
16 hours ago
Watertown, United States Alkermes Full timeJob Description An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities within the business, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This position is...
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Process Engineer
4 weeks ago
Watertown, United States LASE Innovation Inc. Full timeWe are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Engineer. LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex biological problems and diseases by providing access to high-dimensional single-cell...
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Process Engineer 2
1 week ago
Watertown, New York, United States Knorr-Bremse Group Full timeThe Process Engineer responsibilities will involve supporting and improving all machining and special processes. Included in these activities are programming CNC equipment, robotic deburr, Sugino wash and other new automation. Other activities to inc Process Engineer, Engineer, Product Development, Leadership, Equipment, Manufacturing
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Quality Engineer I
4 weeks ago
Watertown, United States Nova Biomedical Full timeNova Biomedical is hiring a Quality Engineer I on-site (hybrid) in our Waltham, MA facility. This role will support Quality Assurance activities within the corporate Quality Management System (QMS). Responsibilities include providing expertise and general oversight for the management and improvement of design and development, validations, quality planning,...
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Process Development Manager
2 days ago
Watertown, United States Alkermes Full timeThe Process Development Manager manages the pilot scale process development facility and personnel and provides technical guidance for small molecule process development, scale-up and technical transfer of developed processes to manufacturing. The successful candidate will thrive in a highly collaborative matrix team environment to drive critical...
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Director, Process Development
2 days ago
Watertown, United States Alkermes Full timeAn exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities within the business, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. All candidates should make sure...
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Quality Engineer I
1 week ago
Watertown, Massachusetts, United States Nova Biomedical Full timeNova Biomedical is hiring a Quality Engineer I on-site (hybrid) in our Waltham, MA facility. This role will support Quality Assurance activities within the corporate Quality Management System (QMS). Responsibilities include providing expertise and general oversight for the management and improvement of design and development, validations, quality planning,...
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Senior Process Engineer
1 month ago
Watertown, United States Via Separations Full timeVia Separations is a rapidly growing Boston-area startup dedicated to eliminating CO2 emissions from industrial manufacturing processes. At the intersection of engineering, society, and impact, our team is passionate about making a difference and building the technology and organization to do it. We are a fast-paced, interdisciplinary team backed by leading...
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Senior Process Engineer
4 weeks ago
Watertown, United States Via Separations Full timeVia Separations is a rapidly growing Boston-area startup dedicated to eliminating CO2 emissions from industrial manufacturing processes. At the intersection of engineering, society, and impact, our team is passionate about making a difference and building the technology and organization to do it. We are a fast-paced, interdisciplinary team backed by leading...
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Field Engineer I
7 days ago
Watertown, United States Skanska USA, Inc. Full timeSkanska is searching for a Field Engineer I. This is a great opportunity to start a career with a company that builds things that matter and values its team. We are proud to share our culture of diversity and inclusion. Our work makes a clear contrib Field Engineer, Engineer, Field, Project Management, Business Services, Support
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Watertown, United States Tome Biosciences Full timeAt Tome, we are developing the next generation of programmable genomic integration technology. Our technologies allow us to insert any genetic sequence of any size at any location into any genome. We are building an exceptional team and a work environment that is diverse, innovative, rewarding, and fun. We have an opportunity to re-write the patient story,...
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Watertown, United States Tome Biosciences Full timeAt Tome, we are developing the next generation of programmable genomic integration technology. Our technologies allow us to insert any genetic sequence of any size at any location into any genome. We are building an exceptional team and a work environment that is diverse, innovative, rewarding, and fun. We have an opportunity to re-write the patient story,...
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Principal, Process Engineer
4 days ago
Watertown, United States Landmark Bio Full timeLandmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the...
