Berkshire Sterile Manufacturing jobs

The Quality Systems Manager is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements at Sharp Sterile Manufacturing (SSM). This role oversees the development, implementation, and continuous improvement of quality systems to support a strong compliance culture. The Quality Systems Manager provides leadership and guidance to the team, fostering a proactive quality mindset across the organization. Duties and Responsibilities Manage and maintain quality systems to support clinical and commercial and development activities at SSM Oversee the Document Control and Quality Systems functions. Oversee the internal audit program Oversee the SSM Client Audit Program Provide quality metrics to Senior QA Management. Assist with Quality System Events (deviations, OOS, CAPA, Change Control, etc.) and chair MRBs Assist with vendor qualification and regulatory audits Ensure that cGMP requirements and quality standards are recognized, understood and maintained Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines Work across all disciplines (e.g. manufacturing, quality control, warehouse and engineering) to ensure that a state of audit readiness is maintained Keep abreast of changes to quality regulations and guidelines and advise the management team of any business implications of these changes Provide quality guidance to development of analytical methods Provide quality guidance to product development projects and programs Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements Supervisory Responsibilities Manage quality activities at BSM Provide leadership to the GMP team related to Quality Culture Experience Five (5) to ten (10) years' experience working in a cGMP environment Five (5) years' experience in a Quality role Three (3) to five (5) years' experience supervising individuals in a cGMP environment Education Bachelor's Degree Relevant experience may be substituted for degree Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs

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

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 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

This person will be responsible for managing process improvements, troubleshooting, and developing corrective and preventative actions. Coordinating, evaluating, and leading engineering projects in the manufacturing facility, with special emphasis on equipment evaluations and implementing solutions using engineering principles, advanced machinery and automation technologies and making recommendations for revision and standardizing of equipment. The goal is to deliver efficient, safe, high quality production output while minimizing unplanned downtime and waste. General Expectations and Supervisory Responsibilities Coordinates and leads Process Improvement projects which pertain to all phases of the sterile fill manufacturing process. Highly organized, self-motivated and independent worker with strong skills in change, problem solving, communication, customer orientation, team skills and quality. Identify, design and implement manufacturing aids (fixtures, jigs, tools, etc.) to reduce manufacturing costs associated with direct labor, scrap and rework. Minimize quality issues and evaluate results; develop and improve manufacturing processes to meet customer and product requirements, introduce products into the production areas and follow products through the entire Manufacture, test, pack and ship process Lead and participating in multiple projects and project teams in the investigation, problem analysis, alternative evaluation and implementation of permanent solutions to chronic issues using data based solutions such as the use of lean problem solving techniques. Provide equipment technical assistance to operations personnel. Bring Best-in-Class techniques, procedures, processes and know-how into the plant operations: equipment, facilities, production processes with focus on analytical solutions. Maintain expertise on equipment with multiple degrees of freedom, manufacturing technology changes, and core process technologies Support daily activities in Operations through staffing and flexible hours; remain on-call for critical operations Work with manufacturing management to identify key areas of equipment and process improvement, then lead the implementation of these changes Support validation activities including equipment validation through collaboration on protocols and aid in execution Lead problem solving and investigations related to filling operations Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Maintenance, Engineering, among others, to develop and maintain processes that meet cGMP and business requirements. Provide construction management oversight for ongoing capital projects Oversee contractors and service providers 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 Prepare and receive work orders as required for repairs and PM contracts with vendors Provide after-hours call-in support for production and utility outages, equipment breakdown and emergency events Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state and federal regulations, or otherwise as applicable Maintain a detailed and comprehensive understanding of USP, FDA, EU Annex 1, and other regulatory agency requirements Maintain qualification on filling operations by successful media fill simulation Experience Five plus (5+) years' experience in aseptic processing, terminal sterilization or lyophilization desired In the absence of above, 5+ years of demonstrated excellence in related technical field, i.e. performing research, technical or field work utilizing scientific or industrial equipment. Education Bachelor's degree in Industrial, Chemical, Manufacturing, or Mechanical Engineering from an accredited college or university Equivalent experience may be substituted for educational requirement Knowledge, Skills & Abilities Excellent technical writing skills 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 Expertise with Microsoft Office Familiar with Quality Management Systems Project management skills Attention to detail 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

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 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

The Project Manager is tasked with establishing, maintaining and enhancing the relationship between BSM and external clients. They interact with many different members of the client's team and internal teams to organize and execute plans that ensure mutual profit. Duties and Responsibilities Duties and Responsibilities (cont'd) Manage project initiation and planning 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 Manage project execution 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 Manage project 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 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 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 N/A Experience One or more (1+) years previous project management experience preferred 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 Education Bachelors' Degree or equivalent work experience required PMP Certification a plus Knowledge, Skills & Abilities Knowledge of project management methods and tools (focusing on MS Suite) Strong listening, and oral and written communications skills required Leadership and team building skills a must Problem-solving skills required Coordination skills a must Excellent oral and written communication skills required Self-starter orientation Conflict management experience a plus Ability to deal with change Physical Requirements Ability to sit and/or stand for prolonged periods of time Able to lift up to 10lbs

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

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 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

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

This person will be responsible for managing process improvements, troubleshooting, and developing corrective and preventative actions. Coordinating, evaluating, and leading engineering projects in the manufacturing facility, with special emphasis on equipment evaluations and implementing solutions using engineering principles, advanced machinery and automation technologies and making recommendations for revision and standardizing of equipment. The goal is to deliver efficient, safe, high quality production output while minimizing unplanned downtime and waste. General Expectations and Supervisory Responsibilities Coordinates and leads Process Improvement projects which pertain to all phases of the sterile fill manufacturing process. Highly organized, self-motivated and independent worker with strong skills in change, problem solving, communication, customer orientation, team skills and quality. Identify, design and implement manufacturing aids (fixtures, jigs, tools, etc.) to reduce manufacturing costs associated with direct labor, scrap and rework. Minimize quality issues and evaluate results; develop and improve manufacturing processes to meet customer and product requirements, introduce products into the production areas and follow products through the entire Manufacture, test, pack and ship process Lead and participating in multiple projects and project teams in the investigation, problem analysis, alternative evaluation and implementation of permanent solutions to chronic issues using data based solutions such as the use of lean problem solving techniques. Provide equipment technical assistance to operations personnel. Bring Best-in-Class techniques, procedures, processes and know-how into the plant operations: equipment, facilities, production processes with focus on analytical solutions. Maintain expertise on equipment with multiple degrees of freedom, manufacturing technology changes, and core process technologies Support daily activities in Operations through staffing and flexible hours; remain on-call for critical operations Work with manufacturing management to identify key areas of equipment and process improvement, then lead the implementation of these changes Support validation activities including equipment validation through collaboration on protocols and aid in execution Lead problem solving and investigations related to filling operations Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Maintenance, Engineering, among others, to develop and maintain processes that meet cGMP and business requirements. Provide construction management oversight for ongoing capital projects Oversee contractors and service providers 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 Prepare and receive work orders as required for repairs and PM contracts with vendors Provide after-hours call-in support for production and utility outages, equipment breakdown and emergency events Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state and federal regulations, or otherwise as applicable Maintain a detailed and comprehensive understanding of USP, FDA, EU Annex 1, and other regulatory agency requirements Maintain qualification on filling operations by successful media fill simulation Experience Five plus (5+) years' experience in aseptic processing, terminal sterilization or lyophilization desired In the absence of above, 5+ years of demonstrated excellence in related technical field, i.e. performing research, technical or field work utilizing scientific or industrial equipment. Education Bachelor's degree in Industrial, Chemical, Manufacturing, or Mechanical Engineering from an accredited college or university Equivalent experience may be substituted for educational requirement Knowledge, Skills & Abilities Excellent technical writing skills 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 Expertise with Microsoft Office Familiar with Quality Management Systems Project management skills Attention to detail 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

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 Quality Systems Manager is responsible for ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements at Sharp Sterile Manufacturing (SSM). This role oversees the development, implementation, and continuous improvement of quality systems to support a strong compliance culture. The Quality Systems Manager provides leadership and guidance to the team, fostering a proactive quality mindset across the organization. Duties and Responsibilities Manage and maintain quality systems to support clinical and commercial and development activities at SSM Oversee the Document Control and Quality Systems functions. Oversee the internal audit program Oversee the SSM Client Audit Program Provide quality metrics to Senior QA Management. Assist with Quality System Events (deviations, OOS, CAPA, Change Control, etc.) and chair MRBs Assist with vendor qualification and regulatory audits Ensure that cGMP requirements and quality standards are recognized, understood and maintained Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines Work across all disciplines (e.g. manufacturing, quality control, warehouse and engineering) to ensure that a state of audit readiness is maintained Keep abreast of changes to quality regulations and guidelines and advise the management team of any business implications of these changes Provide quality guidance to development of analytical methods Provide quality guidance to product development projects and programs Other duties as assigned Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements Supervisory Responsibilities Manage quality activities at BSM Provide leadership to the GMP team related to Quality Culture Experience Five (5) to ten (10) years' experience working in a cGMP environment Five (5) years' experience in a Quality role Three (3) to five (5) years' experience supervising individuals in a cGMP environment Education Bachelor's Degree Relevant experience may be substituted for degree Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs

The Project Manager is tasked with establishing, maintaining and enhancing the relationship between BSM and external clients. They interact with many different members of the client's team and internal teams to organize and execute plans that ensure mutual profit. Duties and Responsibilities Duties and Responsibilities (cont'd) Manage project initiation and planning 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 Manage project execution 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 Manage project 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 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 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 N/A Experience One or more (1+) years previous project management experience preferred 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 Education Bachelors' Degree or equivalent work experience required PMP Certification a plus Knowledge, Skills & Abilities Knowledge of project management methods and tools (focusing on MS Suite) Strong listening, and oral and written communications skills required Leadership and team building skills a must Problem-solving skills required Coordination skills a must Excellent oral and written communication skills required Self-starter orientation Conflict management experience a plus Ability to deal with change Physical Requirements Ability to sit and/or stand for prolonged periods of time Able to lift up to 10lbs

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

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 Monday through Friday 2:30pm - 11:00pm

Job Description 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