Manufacturing Science and Technology Engineer – Maryland
This position will be responsible for ensuring the successful transfer and continued technical support for the company’s processes to meet established timelines and quality objectives. Position will work with Manufacturing, Research and Technology (R&T), Project Management, Marketing, and Quality to successfully transfer processes and systems into Manufacturing. Position will also be responsible for performing technical investigations, identifying opportunities for process improvement, design and implement corrective and preventive actions, and provide technical expertise to multi-departmental teams.
- Perform all functions associated with process transfer and scale up to manufacturing e.g. develop process understanding, perform gap analysis / FMEA, generate process models, author / review Process Descriptions and Batch Records, support equipment commissioning, process training, and validation activities.
- Assist with evaluation of process requirements to ensure facility and equipment capability design can accommodate. Perform calculations to predict volume, time and yield projections. Assist with evaluation of new proposals from prospective customers.
- Provide process equipment troubleshooting to resolve issues that may arise during a manufacturing campaign. Initiate and drive equipment utility change controls to ensure equipment is implemented or repaired within required timeframes.
- As needed, interface with customer technical and quality representatives, represent MSAT group in Project Teams.
- Work directly with Manufacturing, Project Management, Marketing, Supply Chain and R&T and Marketing to develop a bill of materials, to assist in part set-up and write the transfer documents as needed for an incoming process.
- Perform all functions associated with process monitoring and lot releases e.g. manufacturing data summary and analysis, data presentation; author campaign summary reports, assess deviations and process changes.
- Play a key role in resolving technical issues for all functions to improve compliance throughout the site. Serve as investigation lead for process-impacting deviations and investigations. Provide technical guidance on change controls and how they might impact the processes and product specifications.
- Keep current with advances in technology as related to the Biosciences product lines.
- Plan and execute corrective actions to reduce process variability, improve product quality, or streamline production processes. Own CAPAs from start to finish, including implementation.
- Organize, manage and improve Operations activities in support of the development of new products or processes and the manufacture of clinical and commercial products according to cGMPs and/or ISP regulations in a timely manner, right first time in accordance with department objectives.
- Communicate and coordinate clearly / extensively internally with other departments and all stakeholders to drive project completion.
- Ensures corporate cGMP and GLP compliance of all activities performed
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
- Provides appropriate coaching and performance feedback to project teams. Promotes and encourages an Operational Excellence environment.
- Works on complex problems of diverse scope where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises independent judgment within broadly defined practices and policies in selecting or developing methods, techniques and evaluation criteria for obtaining solutions.
- Provides expertise in engineering, design and process scale-up.
- Ensures budgets, schedules, and performance requirements are met. As the team grows, may be responsible for supervision of team members including but not limited to work distribution, scheduling, training and assistance with solving problems.
- Demonstrate success in technical proficiency, creativity, collaboration with others and independent thought.
- Lead complex technical investigations independently with occasional guidance and support.
- PhD degree in chemistry, chemical engineering, biochemistry or biology or equivalent and 5 years of biotech industry experience in process development, process scale up, or manufacturing; or
- MS degree in chemistry, chemical engineering, biochemistry or biology or equivalent and 8 years of biotech industry experience in process development, process scale up, or manufacturing; or
- BS degree in in chemistry, chemical engineering, biochemistry or biology or equivalent and 12 years of biotech industry experience in process development, process scale up, or manufacturing;
- Familiarity with large scale manufacturing, current Good Manufacturing Practices, ISO regulations, and US / EU regulations
- Advanced knowledge of biopharmaceutical manufacturing such as lyophilization, formulation, filling operations, biochemical assays, cell culture, cell isolation, sterile manufacturing, dehydrogenation, media powder and liquid composition, automated manufacturing, packaging, labeling, and aseptic technique.
- Ability to professionally converse about highly technical concepts. Strong verbal and written communication skills; excellent presentation skills
- Experience and knowledge of disposable and single use systems used in bioprocessing
- Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional demeanor.
- Proven leadership ability, especially with indirect reports. Ability to coordinate, facilitate and organize resources.
- Proven ability to perform root cause analysis, FMEA, and develop corrective and preventive actions to reduce likelihood of recurrence.
- Able to independently monitor, analyze and report on problem record trends for the functional areas to reduce non-conformances
- Strong, customer focused orientation with solid follow-up skills and attention to detail.
- Self-motivated, strong work ethic, and ability to “get the job done” and take responsibility for results without direct authority.
- Must possess excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, Power Point, and Project.
This global organization is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. They harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. Not only are they a custom manufacturer and developer, this company also offers services and a wide range of products to include active pharmaceutical ingredients, stem-cell therapies, organic personal care ingredients to agricultural products, and from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria, and other pathogens. The company invests in quality workforce and the culture encourages the employees to challenge themselves and offer a work environment that fosters creativity and success. They have extensive benefits, competitive compensation, and opportunities for advancement.