Berkshire Sterile Manufacturing jobs - 29 jobs

The Director of Manufacturing balances the urgency of daily shift operations with the pursuit of long-term goals while ensuring the highest standards of quality and compliance. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff members to achieve overall organizational objectives. The individual must have the ability to coordinate work between functions to ensure alignment with overall department vision and promote urgency, ownership, and accountability across the organization. Duties and Responsibilities Manage the execution of shift manufacturing to meet quality, client, and financial objectives as well as supporting technical transfer of clinical production activities across shifts Oversee the finite scheduling of aseptic formulation and filling operations to ensure timely batch preparation and filling in alignment with production plans, quality standards, and manufacturing priorities Partner with Quality and Operational Excellence manufacturing management team to ensure consistent product quality; drive efforts to create a right-first time (RFT) culture, reduce and eliminate human errors, manage deviations to ensure true root cause is identified and on time closure is achieved and continuously improve operational performance Proactively identify, assess, and mitigate operational, quality, and organizational risks, escalating key risks and issues Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.) while maintaining high standards of quality, compliance, and safety through leadership by example Implement and drive continuous improvement initiatives across manufacturing operations, leveraging data-driven insights and Operation Excellence methodologies Develop, implement, and maintain KPIs aligned with site objectives to measure and monitor manufacturing performance across key areas including productivity, yield, utilization, cycle times, compliance, and cost efficiency Regularly review and refine KPI metrics to reflect changes in business needs and operational priorities Provide management reporting through use of department metrics aligned with site objectives and balanced scorecard Balance team and individual responsibilities and exhibit objectivity and openness to others' views Facilitate effective communication between clients and internal stakeholders to ensure alignment of site objectives Work to maintain a safe manufacturing environment in accordance with plant/corporate policies and with local, state and federal environmental, health and safety regulations Other duties as assigned Regulatory Responsibilities Assure cGMP compliance with regulatory agencies (FDA, EMA, etc.) Ensure compliance with all local, state, federal, FDA, OSHA, cGMP or other applicable regulations Supervisory Responsibilities Balance team and individual responsibilities Exhibit objectivity and openness to others' views Give and welcome feedback Contribute to building a positive team spirit Put success of team above own interests Build morale and group commitments to goals and objectives Support everyone's efforts to succeed Experience Eight (8) to ten (10) years of supervisory/leadership experience in a GMP manufacturing environment with specific involvement with Operations, Quality and Compliance Management Direct parenteral manufacturing/quality experience preferred Experience in a Lean, Six Sigma or similar Operational Excellence system Education Bachelor's degree from an accredited college or university with a major in Science, Engineering or is preferred An equivalent combination of education and experience may be considered Knowledge, Skills & Abilities Excellent teamwork Ability to communicate clearly and cooperate with other staff members to achieve overall organizational objectives Ability to coordinate work between functions to ensure alignment with overall department vision Ability to promote urgency, ownership, and accountability across the organization Skilled in relational databases and ability to use computerized software to support management reporting including word processing, spreadsheets, charts/graphs and presentations Knowledge of FDA regulations, GMP/GLP/GCP, CFR 210, 211, 610, Part 11, and Parenteral Manufacturing Guidance (FDA/EU Annexes), Lean Manufacturing, Six-Sigma Ability to set and achieve challenging goals Ability to demonstrate persistence and overcome obstacles Ability to measure self against standards of excellence Ability to take calculated risks to accomplish goals Physical Requirements Ability to meet gowning requirements for cleanroom activities Able to lift up to approximately 15-50 pounds frequently and up to 50 lbs. occasionally Frequent standing and walking throughout the facility Use of both hands and arms in repetitive motion Fine and gross motor skills Satisfactory audio-visual acuity

Perform all production operations in the areas assigned within the facility. Perform production support operations in areas assigned and support start-up, changeovers and tech transfer activities. Duties and Responsibilities Operate glass washers and autoclave Prepare buffers, medias and other solutions, following written procedures and batch records Operate process equipment such as tanks, clean in place skids (CIP/SIP), agitators, filtration devices, autoclaves, glass washers, integrity testing and other small equipment Perform process steps in coordination with other associates asking for help as needed so as not to perform steps without proper training/qualification Adhere to scheduling changes and responds appropriately Communicate with supervisor on issues regarding work orders or shifts in process parameters Give input and make suggestions to improve process Follow all GMP's and EHS procedures Attend and completes all mandatory training Ensure training plan is accurate and up-to-date Complete all necessary documentation per the required GMP practices Participate in presenting the manufacturing areas in a state of audit readiness Perform production operations following written SOP's/BR's in accordance with GMPs Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable Supervisory Responsibilities N/A Experience Experience in a GMP environment and in an approved laboratory under minimal supervision preferred Education Associates Degree or High School Diploma with zero (0) to two (2) or more years of directly related experience. Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience Knowledge, Skills & Abilities Understanding of the basic FDA cGMP regulations Verbal and written skills Basic software application skills (Word, Power Point) Able to follow detailed processing instruction Accurately document all necessary documentation Satisfactory audio-visual acuity Ability to read and write English Familiarization with technical issues in the area Ability to work shift that covers a 24/7 operation Ability to work shifts and off hours, as applicable Physical Requirements Ability to sit or stand for prolonged periods of time Ability to lift and carry materials weighing as much as 50lbs

Maintain and enhance the company's quality culture by supporting compliance initiatives and implementing current Good Manufacturing Practices (cGMP) and regulatory requirements. Operate within and support the execution of BSM's Quality Management System. Author, review, and approve documentation required for compliance with FDA, EU, and other applicable regulatory agency requirements. Serve as the primary owner of quality systems, including the review and approval of change controls, deviations, Corrective and Preventive Actions (CAPAs), work orders, and other GMP-related documentation. Assist with and conduct internal audits and routine walkthrough inspections of manufacturing areas; author, review, and approve associated audit reports. Collaborate with cross-functional departments to meet project and compliance objectives. Support the execution of the facility's pest control program. Demonstrate a strong quality mindset in all aspects of work. Conduct business in compliance with all relevant state, federal, and OSHA regulations. Maintain a comprehensive understanding of FDA, EU, and other applicable regulatory requirements. Requirements: Master's degree in Regulatory Affairs or related field (or foreign degree equivalent) and at least 1 year of quality assurance experience in a cGMP environment. At least 1 year of experience reviewing and editing GMP documentation, including change controls, deviations, CAPAs, and SOPs; At least 1 year of experience supporting internal audits and preparing documentation for FDA or other regulatory inspections; At least 1 year of experience performing root cause analysis and developing corrective and preventive actions (CAPAs); At least 1 year of experience using electronic quality management systems (MasterControl, Veeva, or similar); At least 1 year of experience using Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat; At least 1 year of experience with compliance and data integrity best practices; At least 1 year of experience managing various projects and timelines to meet department goals.

The Technical Writer is responsible for creating, revising, and maintaining clear, accurate, and compliant documentation to support pharmaceutical manufacturing operations. This includes standard operating procedures (SOPs), batch records, training materials, and other compliance documents. The role ensures all documentation meets Good Manufacturing Practices (GMP), FDA, EMA, and internal quality standards, and supports cross-functional teams in achieving operational excellence. Technical Writer will be responsible for authoring, reviewing, and controlling all Good Manufacturing Practice (GMP) documentation related to the transfer and scale-up of client drug products. The primary focus of this role is to translate complex technical process descriptions and engineering data into clear, concise, and compliant Master Batch Records (MBRs) for use in aseptic manufacturing operations. Duties and Responsibilities Document Creation & Maintenance: Write, edit, and maintain SOPs, batch records, and other technical documents for manufacturing and operation, based on Tech Transfer documents and process changes. Ensure the MBRs are written clearly for the end-user (Manufacturing Operators) to minimize errors and deviations. Regulatory Compliance: Ensure all documentation complies with GMP, FDA, EMA, and other relevant regulatory standards, as well as internal policies. Collaboration: Work closely with manufacturing, quality assurance, validation, safety, and engineering teams to gather technical information and ensure accuracy and clarity in documentation. Lead document review process, consolidating and incorporating feedback from Subject Matter Experts (SMEs). Process Improvement: Translate complex technical processes into concise, user-friendly instructions to enhance operational efficiency and reduce errors. Document Control: Manage document lifecycle, including version control, reviews, approvals, and archiving, using electronic document management systems (EDMS). Initiate and execute Change Control requests for all MBR and SOP updates. Training Support: Assist in developing training materials based on SOPs and provide support to ensure effective implementation of procedures. Continuous Improvement: Identify opportunities to improve documentation processes, readability, and usability, incorporating feedback from end-users. Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable Supervisory Responsibilities N/A Experience Two plus (2+) years of technical writing experience, preferably in pharmaceutical or sterile manufacturing environments or a CDMO. Education Bachelor's degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or a related field. Certification in Technical Writing (e.g., AMWA, STC) or GMP training is a plus Knowledge, Skills & Abilities Exceptional technical writing and editing skills with a focus on clarity, accuracy, and conciseness. Demonstrated understanding of aseptic processing, cleanroom environment controls, terminology and cGMP manufacturing operations. Proficiency in document management systems (e.g., MasterControl) and Microsoft Office Suite. Ability to work collaboratively with cross-functional teams and manage multiple projects under tight deadlines. Knowledge of regulatory guidelines (e.g., 21 CFR Part 211, ICH Q7). Attention to detail, analytical thinking, and strong organizational skills. Exceptional verbal communication skills. Physical Requirements Ability to meet gowning requirements. Ability to remain stationary for prolonged periods. Satisfactory audio-visual acuity.

The Project Management Supervisor is tasked with establishing, maintaining, and enhancing the relationship between BSM and external clients, understanding and delegating Projects based upon on-going and expanding work orders, managing internal and external deliverables, and leading and mentoring Project management department. Duties and Responsibilities Duties and Responsibilities (cont'd) Initiation and Planning Review scope of work and assign a Project manager Review and approve project kick-off Assist Project managers with prioritization and task definition Work with Sales to establish realistic timelines for potential client Liaise inter-departmentally to establish strong Project teams Review and refine project schedules and timelines Identify resource deficiencies and assist Project managers to overcome resource issues Document and manage project scope Define and prioritize project tasks Establish project goals, requirements, and desired results Create, manage, and update project schedules and timeline Define, manage, and update resources Review requirements and specifications for work Participate in identifying and recruiting project personnel Identify and assign duties, responsibilities, and scope of authority to project team personnel Execution Ensure that Project Managers are maintaining and meeting project schedules and parameters Address Scope creep and identify Change Orders to allocate resources for new/additional work Address project risks and issues when elevated from Project Teams, Elevate further issues to executive team Work Cross-functionally with manager in other departments to meet client deliverables/project goals Maintain strategic level overview and plan for all ongoing projects Manage client visits and requests for escalation Facilitate team meetings to discuss and review the work Act as focal point for project problem resolution and escalation Establish conditions for project closure and manage closure Manage internal project requests and allocate resources Establish schedules and project parameters; develop procedures to accomplish project goals Identify and manage project risk Identify and manage project issues Coordinate the work across multiple projects with other project staff from various functional departments Gather and review status reports prepared by project personnel and modify as necessary Track the execution process to ensure that project team adheres to reporting requirements Facilitate team meetings to discuss and review the work Act as focal point for project problem resolution and escalation Establish conditions for project closure and manage closure Quality Delivery Ensure the quality provided and delivered meets that in the agreed plan Ensure that the team follows all formal and informal best practices in project management and other initiatives Report and Communication Train and mentor Project Managers for increasing responsibilities and knowledge Ensure internal and external communications are accurate and timely Prepare project reports for management, clients or others Facilitate interactive sessions Deliver presentations as required Relationship management Establish and maintain customer relationships appropriately Negotiate with clients and internally to reach optimal delivery resolution Manage customer expectations in delivery Manage vendor relations, as appropriate Other duties as assigned Regulatory Responsibilities Exhibit a quality mindset and a willingness to develop Demonstrated knowledge of FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance Supervisory Responsibilities Included in Duties and Responsibilities Experience Experience in managing multiple projects simultaneously preferred Experience in working with 3rd-party delivery model and structure a plus Experience with process improvement certifications (CMMI) a plus One (1) to three (3) years previous project management experience required One (1) to three (3) years experience in a cGMP Pharmaceutical environment Education Masters' Degree or equivalent work experience required PMP Certification preferred Knowledge, Skills & Abilities Knowledge, Skills & Abilities (cont'd) Knowledge of project management methods and tools Strong listening, and oral and written communications skills required Leadership and team building skills a must Problem-solving skills required Coordination skills a must Self-starter orientation Conflict management experience a plus Ability to deal with change Proficient in Microsoft Office Suite applications Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time Able to lift up to 10lbs

The Sterility Assurance Manager ensures sterility the leads contamination control program, aseptic processing simulation (media fill) program, manages audit interactions related to sterility assurance. Duties and Responsibilities Oversee the Media Fill Program Plan and design aseptic process simulations aligning with regulatory expectations, including frequency, number of runs, and risk‑based requirements. Ensure APS simulates full aseptic processing from sterilization steps through container sealing, including all product-contact and environmental interfaces. Conduct contamination risk assessments and ensure worst‑case scenarios are adequately represented in APS design. Define, own and maintain contamination control strategy for all areas Lead the aseptic Comportment/Training/Oversight Oversee sterilization processes Implement and lead risk assessments and improvement programs against current and future expectations Lead sophisticated investigations into issues impacting Sterility Assurance (i.e. Adverse EM trends, media fill failures) Review & approve any major/critical deviations and change proposals with Sterility Assurance impact for the assigned areas Remain up-to-date with the best approach to sterility assurance Act as Subject Matter Authority (SME) with regulators and customer audits and other interactions. Act as SME to support new product introduction and for applicable capital projects (i.e. new lines/processes) Implement standard methodology Facilitate harmonizing practices across the site Follow all job-related safety and other training requirements Other duties as assigned Regulatory Responsibilities Maintain working knowledge of 21 CFR 210/211, 21 CFR 820, EU Annex 1, and related regulations Ensure all work is performed in accordance with current regulatory requirements and internal SOPs Support data integrity initiatives and provide input to compliance metrics Supervisory Responsibilities Supervise and develop a team of Specialists providing on-the-floor and documentation support. Provide regular feedback, performance evaluations, and coaching to team members. Coordinate staffing to support manufacturing schedules and priority projects. Experience Five plus (5+) years of Microbiology or Sterile Manufacturing experience, ideally within a sterile pharmaceutical manufacturing facility Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site. Experience with pharmaceutical industry technology, especially from a validation, technical or laboratory role would be preferred Education Bachelor of Science Degree in relevant area; e.g. Microbiology, Applied Biology, or similar required Knowledge, Skills & Abilities Involvement in capital projects (new build/refurbishment of sterile lines) would be beneficial Familiarity with U.S. FDA, EU Annex-1 and other regulations and guidance Strong investigative skills, preferably familiar with Root Cause Analysis methods Shown expertise with audits and client-facing roles Outstanding technical writing skills Influencing cGMP Compliance Strong sense of diplomacy and assertiveness Quality Judgement Effective time management and prioritization skills Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters Outstanding attention to detail and organizational skills Self-starter, mature, independent and conscientious Ability to work in a fast-paced environment under pressure Able to multi-task Results-oriented Ability to maintain a high degree of confidentiality Requires discretion and independent judgment Detailed knowledge of aseptic processing and practical experience in an active aseptic manufacturing operation Knowledge of aseptic process simulations (media fills) Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolonged periods of time Ability to lift up to 20lbs

The Maintenance Technician is responsible for the repairs and maintenance of the facility and equipment and achieving departmental objectives. This individual will work on electro mechanical equipment such as Autoclaves, Isolators, Filling Equipment, and Cappers. Duties and Responsibilities Oversee contractors and service providers managing repairs and installations. Perform maintenance work on automated electro-mechanical equipment. Partner with facilities team to provide technical support as required for facility/utility and safety systems Troubleshoot, repair and ensure PM functions are performed on equipment and building components as required and in compliance with all regulatory requirements, including maintaining records and reports Utilize technical knowledge to assist in determining root cause of equipment or system failure and facilitate corrective actions Work with other departments within the company to resolve problems Prepare and execute work orders as required for repairs and PM contracts with vendors Proactive maintenance of facility and production equipment to minimize unplanned downtime. Conduct repairs and maintenance as required Provide after-hours call-in support for production and utility outages, equipment breakdown and emergency events Overtime as required to meet objectives Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA and HIPAA regulations, or otherwise as applicable Carry out job duties and responsibilities in a manner which ensure the safety and well-being of employees, contractors and other individuals Supervisory Responsibilities Supervises and facilitates work by outside contractors for service, preventive maintenance and projects. Experience Minimum of three (3) years general maintenance experience preferably in GMP industry with demonstrated knowledge in all common aspects of building and equipment maintenance. Relevant industry experience in the maintenance of automated equipment is preferred. Education High school diploma. Associates in a technical field or post-secondary Trade School/Technical Institute education preferred. Knowledge, Skills & Abilities Strong mechanical aptitude Knowledge of common materials, engineering methods, process controls and manufacturing systems Proficient with data analysis and applied mathematics Proficiency with Microsoft Office products Managing construction activities Attention to detail Ability to work independently without constant or close supervision Ability to build relationships and influence and/or enforce decisions with peers and management Prioritizing and balancing work from multiple projects in parallel Desire to learn and develop within the organization Ability to read and write in English Physical Requirements Ability to sit for prolonged periods of time and stand for prolonged periods of time as required. Ability to lift up to 50lb occasionally, up to 10 lbs. frequently Ability to meet gowning requirements Satisfactory audio-visual acuity Gross and fine motor skills to manipulate tools

The Quality Control Analytical Associate performs laboratory testing and administrative tasks for the QC department. Testing includes incoming materials, in-process samples, finished good and stability samples. It also includes performing experiments for method transfers, qualifications and validation. The QCA Analyst is responsible for creating and revising documents related to testing such as SOPs, test methods, protocols and reports. The position involves hands on activities such as laboratory testing, sampling of incoming materials, shipment of samples, inspection of samples and visual inspection of finished goods. Duties and Responsibilities Perform laboratory testing of incoming materials, in-process, finished product and stability samples Create documentation necessary to conduct method transfers, qualifications, and validation and perform corresponding experiments Author and revised quality control procedures and specifications Perform laboratory maintenance activities such as temperature checks, ordering laboratory supplies, cleaning, appropriate disposal of laboratory waste Maintain SDS collection Sample and dispense chemicals and manufacturing materials Prepare shipments of samples to contract testing laboratories, including interfacing with outside laboratories Visual inspection of finished goods Ability to work unscheduled and overtime hours as needed Other duties as assigned Regulatory Responsibilities Compliance with FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance Supervisory Responsibilities N/A Experience Zero to two (0-2) years of directly related experience. Up to one (1) year of experience in a cGMP environment under minimal supervision. Education Bachelor's Degree Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications such as Word, Excel, PowerPoint and Adobe Acrobat Physical Requirements Ability to stand and sit for prolonged periods of time Able to lift up to 30lbs

The Senior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers. Duties and Responsibilities Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing Identify and order materials required to perform development and manufacturing Identify tooling and equipment required to perform development and manufacturing Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests Carry out all job responsibilities in a safe manner Develop equipment and processes that meet safety codes, policies and guidelines Provide for the safety and well-being of operators, maintenance, and other personnel Confer with scientists or engineers to conduct analyses of research projects, interpret test results or develop procedure and standard tests Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines Supervisory Responsibilities Lead/support validation activities including equipment validation and process validation Lead problem solving and investigate quality events related to formulation process or batch records Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards Lead or participate in root cause analysis and quality event investigation such as OOS and deviations Supervise, mentor and develop team members or relevant personnel across departments Experience A minimum of three (3) years of experience in pharmaceutical research and manufacturing Education Bachelor's degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science Knowledge, Skills & Abilities Experience in sterile manufacturing is preferred Experience in lyophilization and terminal sterilization techniques are a plus Knowledge of parenteral drug product manufacturing Proficient with calculation, data analysis, statistics and applied mathematics Exceptional computer skills including Microsoft Office, Visio or other related software Excellent writing skills Attention to detail Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolonged periods of time Able to lift up to 50lbs

The Formulation Supervisor is a working supervisor role responsible for all aspects of formulation activities to ensure achievement of the production and quality goals set by management as well as providing support and direction to formulation personnel. Duties and Responsibilities Oversee and participate in daily formulation activities and ensure all scheduled tasks/events are completed Responsible for lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss Maintain weekly/daily schedule Use production schedule and activities, communicate necessary to do tasks to associates and/or leads Communicate and maintain the thaw / equilibration schedules for chemicals and/or equipment Maintain an adequate supply of formulation supplies so as not to impact the production schedule, follow replenishing process as needed Review Master Production Batch records in timely manner and provides suggestions/corrections to PE member Review SOPs accurately for communicating and initiate the documentation change process (DCR/MOC) for needed documentation changes within established timeframes Complete executed Batch Records accurately and complete manufacturing review within established timeframes prior to submission to QA for review Initiate process deviations as they occur within the department, participate in investigations, and contribute to identifying corrective and preventative actions Identify safety risks and alerts management to take corrective action Provide timely communication to management and clients of issues, challenges as well as opportunities for process improvements Other duties as assigned Regulatory Responsibilities Ensure all work is conducted following a high standard of GMP compliance and written SOP and batch records Comply with all area SOPs and ensure logbooks are completed and adhere to cGMP requirements Supervisory Responsibilities Assign and direct work, provide direction, resources and resolve problems Participate in recruiting Provide feedback on performance to Formulation Manager Train team members and ensures proper training is completed prior to assigning tasks Experience Familiar with cGMP regulations and principles and how to apply them to the manufacturing of pharmaceutical/biotech products Two (2) to three (3) years' work experience in formulation within a GMP environment preferably in fill finish pharmaceutical operations or proven ability of same Leadership experience as a team lead of supervisor type role preferred Education Bachelor's degree preferred An equivalent combination of education and experience may be considered Knowledge, Skills & Abilities Possess working knowledge of formulation/compounding processes and equipment cGMP and cGLP practices Experience with Microsoft Office and general computer proficiency Attention to detail Able to follow rules and regulations Mechanical aptitude Resilient, can quickly move forward despite challenges, thrives on challenges to improve skills and abilities Honesty, integrity, respect and courtesy with leadership and peers Ability to build collaborative relationships Supervisory skills Conflict resolution Able to perform complex work instructions and trouble shoot complex problems Physical Requirements Able to meet gowning requirements Visual acuity Fine and gross motor skills to manipulate tools and equipment Able to remain stationary for continuous prolonged periods of time Able to lift 30lbs repeatedly Able to wear PPE Able to be medically qualified to participate in respirator program Able to use standard office equipment with or without reasonable accommodation

The Logistics Associate is a highly organized, process-oriented individual who coordinates and assists multiple departments in day-to-day logistics and finishing activities. This position is associated with activities such as finished inventory tracking, coordinating shipments, preparing inventory for shipments, material storage, receiving shipments, maintaining the accuracy of inventory records and keeping the warehouse orderly and secured. Activities include but are not limited to shipping, packaging, labeling, and administrative work to ensure efficiencies of operations. Duties and Responsibilities Receive, label and store incoming materials in QC hold location Work with Quality Control to release/label materials for GMP use in manufacturing and move to appropriate warehouse location Issue materials to manufacturing and document transactions Process, package and ship orders and document transactions Update inventory system with all movements of inventory items and maintain proper documentation of all transactions Organize stocks and maintain proper status of inventory items Verify and coordinate shipping and labeling projects based on client requests Label generation through vendors and internal processing Assist in coordinating activities with Project Management, Engineering, Quality Assurance, Quality Control, Warehouse and Manufacturing Write and record in labeling and shipping documents based on client and project management direction in accordance to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMPs) Review and monitor batch completion for timeliness, accuracy and fulfillment of client expectations for shipping and packaging projects Maintain accuracy of inventory records through periodic cycle counting Comply with all GMP and safety procedures Keep all areas clean and organized at all times Determine and resolve problems with inventory discrepancies Participate in internal and external audits as applicable Attend and complete all mandatory training Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA and cGMP regulations, or otherwise as applicable. Knowledge of FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance Supervisory Responsibilities N/A Experience Zero to one (0-1) year of directly related experience and at least one (1) year of experience in a GMP environment preferred Education High school diploma or GED required Knowledge, Skills & Abilities Strong organizational skills and attention to detail Basic knowledge of MS Office - Outlook, Word and Excel Ability to operate pallet jack and other warehouse equipment Proficient with use of ERP systems preferred but not required Well-organized and proficient at reviewing and editing documentation Maintain control and confidentiality of documents and information Ability to complete repetitive tasks with minimal errors while documenting information in a detailed manner Ability to work with inventory and physical count numbers with ease Ability to work independently Ability to communicate in a professional manner and work in a fast-paced environment Physical Requirements Ability to lift materials up to 50 pounds Ability to sit and/or stand for prolonged periods of time

The Operations Engineering Manager is responsible for maintaining expertise with and making meaningful contributions to filling and related manufacturing operations to meet desired product specification for all BSM client projects of parenteral drug product manufacturing. The Operations Engineering Manager is responsible for broadly managing the novel creation of bespoke and general solutions for client-needs and / or quality parameter objections. This includes the management of staff, vendors, quality documentation, and functional requirements of process designs, implementation efficacy and training, and conception, fabrication, testing and induction of size or change part kits. The manager must be qualified for filling operations by media fill participation and contribute to contemporaneous process monitoring, improvement, and troubleshooting all fill related operations. Duties and Responsibilities Work with operations, engineering, QA, maintenance, suppliers and management to resolve problems Work with client to identify filling operation quality outcomes Communicate with the clients and internal departments including upper management on project status and results Prepare and review quality documents and reports Suggest and partake in continuous improvement initiatives Provide feedback on, and propose solutions regarding process improvement initiatives to improve operating performance Lead CAD-based part designs to empower process improvement Due diligence on process design and risk analysis to ensure operation safety, efficiency and quality Review MFG operations batch records and other quality documents and reports Review and approve study protocols to evaluate manufacturing processes and write associated summary reports Create documents for operation and quality such as master batch records, working closely with the quality unit. Develop and / or revise SOPs for equipment operations as needed Accurately document and record (GDP) necessary data and reports with appropriate conclusions Complete quality events such as deviation with sound judgement and scientific principal in a timely fashion Maintain expertise on equipment with many degrees of freedom and manufacturing technology changes and core process technologies Support daily activities in Manufacturing Operations and be able to work flexible hours and/or remain on-call for critical operations Create and maintain control charts, key performance metrics and trending data from assigned areas to communicate process controls and improvements Evaluate manufacturing processes and equipment and suggest improvements to increase reliability, throughput, minimize waste/rework. Work directly with manufacturing management to identify key areas of equipment and process improvement In conjunction with manufacturing personnel, evaluate new manufacturing equipment, prepare operating procedures and develop training. Oversee modifications to manufacturing equipment as required/requested by Manufacturing, manage associated change controls and work orders Have ownership of assigned equipment or business processes Maintain up-to-date timelines and meet agreed upon deadlines Source equipment and develop processes that meet safety requirements and provide for the safety and well-being of operators, maintenance and other personnel Keep up industry knowledge and provide trainings in equipment and manufacturing technology Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements Supervisory Responsibilities Supervise/execute technology transfer of new processes or equipment Support daily activities in the assigned areas and be able to work flexible hours and/or remain on call for critical manufacturing operations Support validation activities including equipment validation and process validation Lead problem solving and investigate quality events related to filling operations Propose and lead process improvement initiatives to improve operating performance Supervise, mentor, and develop team members or relevant personnel across departments Experience Five plus (5+) years' experience in aseptic processing, terminal sterilization or lyophilization desired In the absence of above, 5+ years of hands-on work in a technical field performing research, or field work utilizing scientific or industrial equipment. Three plus (3+) years of supervisory/management experience Education Advanced degree expected Minimum of Bachelor's degree in Chemical Engineering, Chemistry, Biology, Engineering or Pharmaceutical Science AND relevant experience Knowledge, Skills & Abilities Expertise with 3D / CAD modeling and ANSI drafting Knowledge of scientific best practices Excellent in technical writing Knowledge of engineering first principles Knowledge of parenteral drug product development and manufacturing Able to work in a dynamic environment and adapt to changing priorities Excellence in solving complex engineering and / or scientific problems Able to handle multiple projects Expertise with Microsoft Office Familiar with Master Control Project management skills Excellent writing skills Attention to detail Written and oral communication skills Physical Requirements Ability to meet gowning requirements Ability to remain stationary for prolonged periods of time Ability to periodically lift up to 50 lbs. Satisfactory audio-visual acuity Gross and fine motor skills to manipulate instruments

The IT Manager will manage IT staff and the BSM help desk by providing technical advice and oversight for network applications for both new and existing systems at BSM. Duties and Responsibilities Resident SME for information technology and solutions Manage help desk through support ticket generation, tracking and resolution Coordinating activities with technology vendors and supporting technology contractors to design, setup or troubleshoot systems Maintain organized records of company technology related documents, software licenses and computerized equipment Continuously strive to improve the company computerized systems with a focus on quality, timeliness and cost-awareness Administrative ad hoc review of reports and management of records Adopt corporate policies and standard operating procedures (SOPs) and develop plant specific SOPs for all IT activities Act as system administrator for plant systems Create and perform training with employees on IT related topics (account security, application troubleshooting, new user training, etc.) Manage quality change controls, CAPAs, deviations, events related to IT Other duties as assigned Regulatory Responsibilities Monitor and control security of company computerized systems, assess 21 CFR Part 11 compliance and respond with necessary corrective actions Ensure BSM IT/IS systems are operating efficiently and in compliance with FDA regulations and BSM approved procedures Supervisory Responsibilities Oversee day to day activities and training of the IT group Provide leadership to maintain and improve BSM technology Provide guidance and mentorship to IT technicians Experience Four (4) years related technology experience or combination of education and work experience One (1) year experience in cGMP and/or FDA regulated industry IT related certifications preferred Education Bachelor's degree or equivalent education and experience Knowledge, Skills & Abilities Proficient in MS Office applications (including Word, Excel, Powerpoint and Outlook), Windows OS, basic networking devices Familiarity with Active Directory, Azure, MS Exchange, MS Teams is required Knowledge of RJ45 wiring required Good customer service skills Familiarity with databases and SQL software is preferred Well-organized Proficient at troubleshooting Attention to detail while executing multiple tasks, maintaining accurate records and files Ability to manage timelines to meet assigned goals Maintain control and confidentiality of documents and information Demonstrated effective management of small teams Ability to communicate in a professional manner and work in a fast-paced environment Physical Requirements Use of standard office equipment with or without reasonable accommodation(s) Ability to remain stationary for prolonged periods of time Walk between work areas Lift up to 10lbs. frequently and up to 50 lbs. occasionally Perform low voltage wiring and wire running in confined areas

Perform all formulation operations in the area of assignment and support start-up/changeovers/tech transfer activities. This position works under the immediate direction of the Formulation Supervisor and all work is conducted following a high standard of GMP compliance and written SOP and batch records. Duties and Responsibilities Operate glass washers and autoclave, prepare buffers and medias and other solutions Operate process equipment such as tanks, filtration devices, autoclaves, glass washers, integrity testing and other small equipment Daily completion of formulation activities ensuring all scheduled tasks/events are completed Formulation process steps including but not limited to, lab setup and process flows, in-process testing, API dissolution and final QS while ensuring safety, batch integrity and prevention or errors that could lead to product and or financial loss Initiate the production of batch used for engineering and cGMP production and initiate thawing of the API as required Execute Batch Records accurately and complete prior to submission for review Author process deviations when they occur within the department, participate in investigations and contribute to identifying corrective and preventative actions Cross train to increase technical skills across the department Communicate, in a timely manner, to management and clients of issues, challenges as well as opportunities for process improvements Other duties as assigned Regulatory Responsibilities Comply with all area SOPs and ensure logbooks are completed, and adhere to cGMP requirements Conduct all work in compliance with FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance Supervisory Responsibilities N/A Experience Formulation Associate I - Zero to two (0-2) years' experience in a GMP environment performing and using formulation/compounding processes and equipment Education Formulation Associate I - Associates Degree in a science-related discipline or equivalent GMP experience Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience Knowledge, Skills & Abilities Possess working knowledge of formulation/compounding processes and equipment Attention to detail cGMP and cGLP practices Demonstrated ability to prioritize multiple projects and activities Can perform routine work instructions and trouble shoot routine problems referring more complex issues to Formulation Supervisor Experience with Microsoft Office and general computer proficiency Effective communication and availability Able to work effectively with others Physical Requirements Ability to meet gowning requirements Visual acuity Fine and gross motor skills to manipulate tools and equipment Ability to remain stationary for continuous prolonged periods of time Able to lift 30lbs repeatedly Able to wear PPE Medically qualified to participate in respirator program Use of standard office equipment with or without reasonable accommodation

Employment Type: Full-time Salary Range: $64,397.00 to $77,920.00 annually * Maintain and enhance the company's quality culture by supporting compliance initiatives and implementing current Good Manufacturing Practices (cGMP) and regulatory requirements. * Operate within and support the execution of BSM's Quality Management System. * Author, review, and approve documentation required for compliance with FDA, EU, and other applicable regulatory agency requirements. * Serve as the primary owner of quality systems, including change controls, deviations, Corrective and Preventive Actions (CAPAs), work orders, and other GMP-related documentation. * Assist with and conduct internal audits and routine walkthrough inspections of manufacturing areas; author, review, and approve associated audit reports. * Collaborate with cross-functional departments to meet project and compliance objectives. * Support the execution of the facility's pest control program. * Demonstrate a strong quality mindset and conduct business in compliance with all relevant state, federal, and OSHA regulations. * Maintain a comprehensive understanding of FDA, EU, and other applicable regulatory requirements. Requirements: * Master's degree in Regulatory Affairs or related field (or foreign degree equivalent) * At least one (1) year of quality assurance experience in a cGMP environment. * At least (one) 1 year of experience reviewing and editing GMP documentation, including change controls, deviations, CAPAs, and SOPs. * At least (one) 1 year of experience supporting internal audits and preparing documentation for FDA or other regulatory inspections. * At least (one) 1 year of experience performing root cause analysis and developing corrective and preventive actions (CAPAs). * At least (one) 1 year of experience using electronic quality management systems (e.g., MasterControl, Veeva, or similar) * At least (one) 1 year of experience using Microsoft Office (Word, Excel, PowerPoint) and Adobe Acrobat. * At least (one 1 year of experience with compliance and data integrity best practices. * At least (one) 1 year of experience managing multiple projects and timelines to meet department goals. Application & Inquiries Interested individuals may apply through the company's Careers website. For questions or inquiries regarding this position, please contact: Travis P. Ruscio Corporate Recruiter Sharp Sterile Manufacturing ************************

The Facility Technician will service, maintain, repair, inspect, and monitor various plant equipment including the boiler. Duties and Responsibilities Monitor facility equipment for alarms during the weekend shifts Perform facility/utility rounds Inspect, maintain, troubleshoot and repair steam boilers, hot water heating systems and all related equipment Steam, water, compressed air, and gas leak repairs Pump and valve maintenance, repair, and testing Record keeping, including daily logs Monitor physical plant system operations General facility repair including paint and drywall. Maintain a safe and clean working environment Other duties as assigned Regulatory Responsibilities Adherence to established company safety policies and good industrial and office safety practices. General understanding of cGMP, 21 CFR 210/211 and other regulatory agency requirements. Supervisory Responsibilities N/A Experience Experience or proven ability in general facility/utility maintenance Education High School Diploma or equivalent (GED) Post-secondary Trade School/Technical Institute education preferred Boiler license preferred or ability to obtain required Knowledge, Skills & Abilities Knowledge, Skills & Abilities (cont'd) Able to complete training provided on all equipment within the facility Use of common mechanical and electrical tools Communicate and working effectively with others Meet work conditions and physical demands, with or without accommodations, on a continuous basis Proper use of personal protective equipment related to tasks Proper application of Lockout Tag out, confined space, and other safety procedures Satisfactory audio-visual acuity Ability to read and write English Able to work independently with minimal supervision Physical Requirements Able to walk, bend and reach Able to sit or stand for prolonged periods of time Able to lift and carry materials weighing as much as 50lbs

The Project Management Supervisor is tasked with establishing, maintaining, and enhancing the relationship between BSM and external clients, understanding and delegating Projects based upon on-going and expanding work orders, managing internal and external deliverables, and leading and mentoring Project management department. Duties and Responsibilities Duties and Responsibilities (cont'd) Initiation and Planning Review scope of work and assign a Project manager Review and approve project kick-off Assist Project managers with prioritization and task definition Work with Sales to establish realistic timelines for potential client Liaise inter-departmentally to establish strong Project teams Review and refine project schedules and timelines Identify resource deficiencies and assist Project managers to overcome resource issues Document and manage project scope Define and prioritize project tasks Establish project goals, requirements, and desired results Create, manage, and update project schedules and timeline Define, manage, and update resources Review requirements and specifications for work Participate in identifying and recruiting project personnel Identify and assign duties, responsibilities, and scope of authority to project team personnel Execution Ensure that Project Managers are maintaining and meeting project schedules and parameters Address Scope creep and identify Change Orders to allocate resources for new/additional work Address project risks and issues when elevated from Project Teams, Elevate further issues to executive team Work Cross-functionally with manager in other departments to meet client deliverables/project goals Maintain strategic level overview and plan for all ongoing projects Manage client visits and requests for escalation Facilitate team meetings to discuss and review the work Act as focal point for project problem resolution and escalation Establish conditions for project closure and manage closure Manage internal project requests and allocate resources Establish schedules and project parameters; develop procedures to accomplish project goals Identify and manage project risk Identify and manage project issues Coordinate the work across multiple projects with other project staff from various functional departments Gather and review status reports prepared by project personnel and modify as necessary Track the execution process to ensure that project team adheres to reporting requirements Facilitate team meetings to discuss and review the work Act as focal point for project problem resolution and escalation Establish conditions for project closure and manage closure Quality Delivery Ensure the quality provided and delivered meets that in the agreed plan Ensure that the team follows all formal and informal best practices in project management and other initiatives Report and Communication Train and mentor Project Managers for increasing responsibilities and knowledge Ensure internal and external communications are accurate and timely Prepare project reports for management, clients or others Facilitate interactive sessions Deliver presentations as required Relationship management Establish and maintain customer relationships appropriately Negotiate with clients and internally to reach optimal delivery resolution Manage customer expectations in delivery Manage vendor relations, as appropriate Other duties as assigned Regulatory Responsibilities Exhibit a quality mindset and a willingness to develop Demonstrated knowledge of FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance Supervisory Responsibilities Included in Duties and Responsibilities Experience Experience in managing multiple projects simultaneously preferred Experience in working with 3rd-party delivery model and structure a plus Experience with process improvement certifications (CMMI) a plus One (1) to three (3) years previous project management experience required One (1) to three (3) years experience in a cGMP Pharmaceutical environment Education Masters' Degree or equivalent work experience required PMP Certification preferred Knowledge, Skills & Abilities Knowledge, Skills & Abilities (cont'd) Knowledge of project management methods and tools Strong listening, and oral and written communications skills required Leadership and team building skills a must Problem-solving skills required Coordination skills a must Self-starter orientation Conflict management experience a plus Ability to deal with change Proficient in Microsoft Office Suite applications Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time Able to lift up to 10lbs

The Quality Control Analytical Associate performs laboratory testing and administrative tasks for the QC department. Testing includes incoming materials, in-process samples, finished good and stability samples. It also includes performing experiments for method transfers, qualifications and validation. The QCA Analyst is responsible for creating and revising documents related to testing such as SOPs, test methods, protocols and reports. The position involves hands on activities such as laboratory testing, sampling of incoming materials, shipment of samples, inspection of samples and visual inspection of finished goods. Duties and Responsibilities Perform laboratory testing of incoming materials, in-process, finished product and stability samples Create documentation necessary to conduct method transfers, qualifications, and validation and perform corresponding experiments Author and revised quality control procedures and specifications Perform laboratory maintenance activities such as temperature checks, ordering laboratory supplies, cleaning, appropriate disposal of laboratory waste Maintain SDS collection Sample and dispense chemicals and manufacturing materials Prepare shipments of samples to contract testing laboratories, including interfacing with outside laboratories Visual inspection of finished goods Ability to work unscheduled and overtime hours as needed Other duties as assigned Regulatory Responsibilities Compliance with FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance Supervisory Responsibilities N/A Experience Zero to two (0-2) years of directly related experience. Up to one (1) year of experience in a cGMP environment under minimal supervision. Education Bachelor's Degree Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications such as Word, Excel, PowerPoint and Adobe Acrobat Physical Requirements Ability to stand and sit for prolonged periods of time Able to lift up to 30lbs

The Senior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers. Duties and Responsibilities Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing Identify and order materials required to perform development and manufacturing Identify tooling and equipment required to perform development and manufacturing Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests Carry out all job responsibilities in a safe manner Develop equipment and processes that meet safety codes, policies and guidelines Provide for the safety and well-being of operators, maintenance, and other personnel Confer with scientists or engineers to conduct analyses of research projects, interpret test results or develop procedure and standard tests Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines Supervisory Responsibilities Lead/support validation activities including equipment validation and process validation Lead problem solving and investigate quality events related to formulation process or batch records Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards Lead or participate in root cause analysis and quality event investigation such as OOS and deviations Supervise, mentor and develop team members or relevant personnel across departments Experience A minimum of three (3) years of experience in pharmaceutical research and manufacturing Education Bachelor's degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science Knowledge, Skills & Abilities Experience in sterile manufacturing is preferred Experience in lyophilization and terminal sterilization techniques are a plus Knowledge of parenteral drug product manufacturing Proficient with calculation, data analysis, statistics and applied mathematics Exceptional computer skills including Microsoft Office, Visio or other related software Excellent writing skills Attention to detail Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolonged periods of time Able to lift up to 50lbs