Alkermes jobs - 24 jobs

is based in Wilmington, OH Hours: Sunday to Thursday 2300 to 0730 Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR's with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System. Job Description: * Read and follow detailed written SOP's/MPR's/Procedures. * Document all work as required by cGMP's on a timely basis. * Execute tasks as directed with close attention to detail. * Monitors process with close attention to detail. * Follows Alkermes internal policies. * Abide by all safety requirements as defined by the company. * Perform Aseptic Gowning and maintaining gowning qualification. (this includes wearing of hood, coverall, boots, mask, goggles, gloves) * Perform clean room sanitizations. * Perform equipment prep/assembly/setup. * Operate equipment used in filling of microspheres/suspensions/liquid products. * Assist with Development and Validation activities as required. * Other tasks as assigned by Manager. * Shift coverage and weekend work may be required. SKILLS/ABILITIES: * General knowledge of aseptic fundamentals. * General math skills, including using metric weight system. * General Knowledge and Adherence to Current Good Manufacturing Practices. * General Knowledge HAZCOM RCRA, and other safety requirements. * Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment. * General computer skills. * Excellent documentation skills. PERSONAL ATTRIBUTES: * Positive Attitude * Integrity/Ethics * Adaptability/Flexibility * Dependability * Detailed Oriented * Self-Motivated * Responds Quickly to Assignments * Works Well in a Team Environment. * Adapts Well to Changing job duties. * Takes Ownership and is Willing to Learn new tasks/skills Physical Requirements: * Occasional periods of repetitive motion. * Aseptic gowning must be maintained, including an annual requalification. * Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. * Ability to operate all types of production equipment (i.e., Rockwell HMI, Autoclaves, etc.) * Ability to read, understand, and accurately follow company SOP's and guidelines. * Ability to lift/move up to 50 lbs. overhead. Ability to team lift up to 100 lbs. * Ability to stand in steel-toed shoes for a minimum of 7 hrs. Minimum Education & Experience Requirements: MANUFACTURING ASSOCIATE 1 Basic Requirements: * High School diploma or equivalent. Preferred Requirements: * 0-1 year of experience in a sterile pharmaceutical operation. * Associates degree or higher in science/technical discipline. MANUFACTURING ASSOCIATE 2 Basic Qualifications: * High School diploma or equivalent. * 1-3 years of pharmaceutical manufacturing or equivalent experiences. Preferred Qualifications: * 1+ year in a sterile pharmaceutical operation. * Associates degree or higher in science/technical discipline. MANUFACTURING ASSOCIATE 3 Basic Qualifications: * High school diploma or equivalent. * 4-5 years of pharmaceutical manufacturing or equivalent experiences. Preferred Qualifications: * 2-3 years of experience in a sterile pharmaceutical operation. * Associates degree or higher in science/technical discipline #LI-AH1

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: KBI Biopharma is seeking a highly skilled Senior Program Manager (Global PMO Operations) to support critical project management initiatives, ensure financial oversight, and support multiple Programs across the global portfolio. Lead customer survey efforts, support global PMO operations, assisting the refinement of business processes, schedule management, overseeing global financial reporting, and data transitions to SAP and driving data migration efforts. The ideal candidate will have a strong background in program management, financial reporting, and enterprise system migrations, ensuring alignment with business objectives and operational excellence. Responsibilities: Ensure alignment of PMO operations with corporate objectives, driving efficiency and continuous improvement. Support business intelligence data collection for programs in the global portfolio. Collaborate cross-functionally with stakeholders, ensuring project timelines are tracked and budgets are effectively managed. Develop and implement best practices, processes, and governance frameworks to optimize project execution within the Global PMO Operations. Provide regular updates, reports, dashboards and presentations on project status, risks, and mitigation strategies. Perform global financial reporting efforts, ensuring accuracy and compliance with organizational financial policies. Generate and analyze revenue backlog reports, providing insights to leadership for strategic decision-making. Monitor and manage the product intelligence data for the projects in global portfolio. Revision of customer survey, follow-up and metric analysis. Upkeep of SOPs for various business processes to streamline PMO operations Collaborate with business stakeholders and technical teams to understand data requirements and provide insights to support decision-making processes. Design and develop custom reports in Planview to support cross-functional teams across the organization. Design and develop interactive dashboards and reports using Planview tool and partner with stakeholders to develop KPIs and performance metrics to track business performance. Serve as the Data Lead for the preparation, cleansing, and validation of data for transition/migration to SAP from Planview to SAP-ERP system especially for strategic clients. Perform testing in QA and production environments to support the SAP-ERP readiness. Work closely with IT and business teams to streamline the data transition process and troubleshoot migration challenges for strategic clients. Act as the key liaison between senior leadership, finance teams, IT, and project technical teams to ensure seamless communication. Oversee and manage programs and projects, including building project structure on Planview & Propel, and perform financial management activities. Requirements: Bachelor's or master's degree in business, Finance, Project Management, or a related field. 7+ years of experience in project/program management within a global PMO or similar operational function. Experience in managing large-scale financial reporting, revenue backlog management, and enterprise system transitions (SAP preferred). Strong proficiency in Planview, Propel, and financial management tools. Expertise in data migration, cleansing, and governance for enterprise systems. Excellent communication, stakeholder management, and problem-solving skills. Expertise in generation of business and product intelligence data. Salary Range: $118,000 - $162,800 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Alkermes is currently seeking a temporary Researcher for our Manufacturing Sciences and Technology department, Analytical section. This position requires the individual to have laboratory experience in chemistry, biology, or pharmaceutical sciences with an emphasis on HPLC, UPLC, and GC instrumental techniques. This individual will be responsible for setting up and executing experiments such as LC assay, GC residual solvents, molecular weight determination, dissolution and in-vitro analyses, particle size and surface area determination. The Researcher is expected to coordinate sample testing, work efficiently, document results, and communicate findings in a timely manner. KEY RESPONSIBILITIES: * Perform and record analyses. * Adhere to GDP's in all work practices. * Assist in maintaining a clean, safe workplace on a daily basis. * Review peer's work as needed. * Review revisions to procedures as needed. * Assist with chemistry lab/product investigations and studies. * Method development and optimization. * Accountable to the team leader (and rest of department) for ensuring proactive execution of work assignments. SKILLS/ABILITIES: * Experience with Empower chromatography data acquisition and analysis software (preferred). * Experience with HPLC & UPLC (Waters preferred) and GC instrumentation (headspace experience preferred). * Strong verbal and written communications skills. * Maintain laboratory notebook and records in accordance with GDP including timely recording of information and review. * Ability to function in an analytical laboratory environment; should have no known sensitivities to chemicals present in the laboratory and no health conditions that preclude their working in a chemical laboratory environment. EDUCATION AND EXPERIENCE: * Bachelor or advanced degree in Chemistry, Biology, Pharmaceutical Sciences or science related discipline. * 2-5 years of Industrial work experience with HPLC, UPLC, and/or GC or equivalent educational experience.

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I: Job Summary Reporting to the CIO, the VP/CISO, will provide strategic and tactical leadership of global information security, disaster recovery, IT risk management, computer systems validation and compliance programs for the enterprise. He/she will establish and evolve the Information Security strategy & roadmaps to meet or exceed all regulatory agencies, government, client partnerships and compliance mandates utilizing a standard risk-based framework that can provide consistent & repeatable practices. This leader will drive the technology and architectural direction including awareness programs that enables effective & lean delivery across the business & IT organizations that achieves cost optimization, quality improvement, bottom-line results while protecting and enabling the business from the evolving security threat landscape. The individual seeking this opportunity will be a strong thought & people leader with excellent communication skills that allow complex security concepts & risk topics be translated to reach diverse levels in the organization at the appropriate pace & speed. This person is the key liaison and therefore must be an excellent collaborator across multiple disciplines including: business stakeholders, executive level technology risk areas, regulatory agencies, compliance partners & the Board of Directors. II: Responsibilities Key Responsibilities: Sets the vision, strategy & direction for the development & implementation of comprehensive information security, disaster recovery, IT risk management & compliance programs. Own Board of Directors & Executive level communication and interaction including consulting, understanding of business strategies and translating complex information security threats, risks & programs into achievable, sustainable and innovative technology solutions, capability maturity roadmaps. Develop and deliver a tiered security dashboard appropriate for each level of cybersecurity governance. Proactively identify problems, measure progress and continuously improve cybersecurity operations. Create & lead the development of an enterprise Information security awareness program to ensure compliance & that the organization understands the trade-off between risk and return. Understand and translate the trade-offs required to manage the different levels of risk tolerance and risk exposure across the organization and balance this with risk investments Leads team to successfully implement security standards, procedures & guidelines for the enterprise as well as reporting security performance against established security metrics. Ensures and monitors security compliance with industry and government rules and regulations. (e.g., GDPR, HIPAA, ISO 27001, SEC) Build, develop and retain cybersecurity talent. Support employees in their career development by providing guidance on career paths, opportunities for advancement, and skill development. Develop and implement initiatives to enhance employee engagement, satisfaction, and retention. Liaise with external agencies, such as law enforcement and other advisory bodies as necessary, to ensure that the organization maintains a strong security posture. Monitor the external threat environment for emerging threats and advise relevant stakeholders on the appropriate courses of action. Develop and oversee effective disaster recovery policies and standards to align with enterprise business continuity management program goals. Set the vision, strategy, and direction for the organization incident response management program. Integrate with the business continuity and crisis management programs. Provide leadership of the IT Computer Systems Validation (CSV) team responsibilities and accountabilities. Provide strong leadership through mentoring, career development, teamwork, values, to increase overall employee engagement Fiscal stewardship in all aspects in all areas of responsibility The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. III: Education, Experience & Skills Bachelor's degree in IT, business, or related discipline required; Master's degree in Business Administration or related field preferred Minimum of 15+ years of experience in Information Security Minimum of 5+ years of experience as Chief Information Security Officer (CISO) serving as an organizations lead security executive Minimum of 7 - 10 years of experience within the pharmaceutical industry, preferably within pharmaceutical manufacturing facility operations. Technical understanding of applications, networks, and databases. Understanding of Cloud technologies (e.g. SaaS, PaaS, IaaS) Experience in the Defense industry preferred. Industry recognized certifications in the information security and risk management fields with knowledge of national and international regulatory compliances & frameworks. Deep understanding of CSV guidelines issued by regulatory agencies including FDA and MHRA and standards such as GAMP5. Well respected team player with excellent skills at building and managing relationships at all levels with a demonstrated ability to manage cross-functional teams. Visionary leader with strong business acumen and a detailed working knowledge of information security technologies, practices, policies, and their application A great communicator in both written and oral communication. A passion for quality and value in all that is delivered. A no nonsense approach to getting things done. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from [$267,500 to $323,600]. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: ************************************************************* (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Job Description - Engineer, Mechanical Responsible for supporting the growth and ongoing operation of the site facility as the technical owner of HVAC systems. Ensure the proper design and modification of HVAC systems to deliver the capability to consistently meet internal customer demands in a safe & compliant manner. Responsible for supporting the operation of the facility by assisting in troubleshooting /optimization of plant systems. This position will work closely with Project Management, Maintenance, Facility and Process System Owners, Site Operations, EHSS & Supply Chain to establish user requirements, discipline related strategies, assist with budgets, and key schedule milestones for project activities. Project activities are supported through a combination of matrixed and dedicated internal and external resources, and the position requires close and open communication with all parties including key stakeholders. Major Duties/Responsibilities: * Primary responsibility is to ensure that the design & installation of HVAC systems are capable of meeting user requirements, are safe and meet regulatory requirements of cGMP and applicable codes. * Participation on or Leadership of Capital and Improvement project teams from initiation through execution, including development and implementation of HVAC strategy to meet primary requirements and address project considerations of cost and schedule. * Develop project conceptual designs of HVAC systems, define project parameters, and establish detailed designs utilizing internal and/or external resources. Perform and lead design reviews, submittal reviews, document and communicate revisions, and track overall design. * Ensure efficient communication of project status, potential problems and resolutions to issues. * Work with Supply chain to secure proposals, select vendors/contractors, submit purchase requisitions, obtain/review/coordinate submittals, and ensure timely deliveries through expediting and overall coordination. * Direct and coordinate field contracted personnel through installation and start-up while ensuring Quality and Safe work activities. * Assist maintenance with development facility systems operation procedures, preventive maintenance planning, replacement decisions and spare parts inventory assessment. * Provide support for troubleshooting and repair strategies for equipment/systems as necessary. * Work with internal and external Commissioning and Qualification resources to provide qualified installations while ensuring all proper documentation as required by local/state/federal regulators is available. * Assist in maintaining controlled CAD facility and system drawings. Knowledge/Skills: * Skilled Engineer in design, installation, start-up, and commissioning of typical Pharmaceutical Mechanical Systems including HVAC, Chilled Water, Steam, Heating Hot Water, Humidification, Dehumidification and associated Control systems * Knowledge of Clean room HVAC systems design including air pressurizations and HEPA filtration. * Exceptional communication, coordination, and organizational skills * Broad knowledge and technical skills in engineering, procurement, construction management, equipment start-up, and commissioning/qualification activities. * Have a good understanding and general knowledge of the Pharmaceutical industry with regards to current Good Manufacturing Practices (cGMP) * Demonstrated ability to deal effectively across multiple functional departments in a matrixed project team structure. * Demonstrated success in building, leading, and participating on high-performing teams. * Presentation abilities to technical and management teams * Proficient in MS Office software programs including Word, Excel, PowerPoint, and Project. Lead Engineer Education & Experience: * BS degree in a relevant engineering discipline, or equivalent combination of education and work experience * Minimum 5- 8 years of experience in Design, Construction, and/ or Facility Engineering fields * Pharmaceutical industry experience a plus Sr. Engineer Education & Experience: * BS degree in a relevant engineering discipline, or equivalent combination of education and work experience * Minimum 8- 10 years of experience in Design, Construction, and/ or Facility Engineering fields * Pharmaceutical industry experience a plus Personal Attributes Needed: * Self-starter; highly detail and results-oriented * Ability to interact readily with personnel across different departments and to engage senior site management to achieve project success * Fosters collaborative relationships within and across groups through influencing and negotiation skills * Logical problem-solving skills * Demonstrates ability to work within and contribute to highly effective teams * Ability to effectively communicate with various levels of Engineering and Construction personnel * Effectively manage conflict and differences of opinion Physical Demands and Work Environment: * Office, Manufacturing, and Construction work environments. #LI-AH1

Director, Validation Provide leadership for all validation activities within Alkermes organization including clinical and commercial manufacturing support via facilities/equipment/filter/cleaning & manufacturing process validation, capital project support via commissioning and qualification, computer systems qualification, and oversite of entire validation program. Position includes management responsibilities for internal and contractual employees. This position description/summary reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. Responsibilities Development and oversight of corporate validation program to ensure compliance with cGMPs, FDA and EU guidelines. This includes guideline and policy development and enforcement. Responsible for preparation and management of corporate validation budget which includes clinical and commercial operations support and capital projects. Mentoring and developing staff which entails selecting and grooming department management team. Also, provide continuous assessment of team and implementation of various training programs to mitigate department weakness with respect to technical and compliance topics. Participate on various Alkermes quality and technical teams. Participate in corporate Capital Project Review Team and act as Quality representative. Develop and utilize department metrics as a tool for continuous improvement. Clearly define departmental roles and responsibilities with respect to internal and external boundaries. Provide annual reviews for departmental management team which includes establishment of individual goals and objectives. Review and approve departmental purchase requisitions. Translate corporate vision and goals into departmental goals and initiatives and provide oversight for success. Collaboration on site goals and policy creation along with assurance that tactical implementation of goals and policies are adhered to. Anticipate, analyze, and resolve issues within local Quality department as well as interdepartmentally. Create conditions and emphasize inclusion of all involved departments as necessary. Qualifications Bachelor's Degree in relatable field required. 12+ years' experience in cGMP pharmaceutical manufacturing environment. Supervisory Experience: minimum of 6 years. Working knowledge of Quality Systems. Detailed knowledge of all aspects of validation. Detailed working knowledge of GMPs, FDA Aseptic Processing Guideline, EU “Orange Book”, GAMP, and ICH guidelines. Experience and understanding of complex projects and ability to make key decisions based on corporate drivers (best interest of the company). Work with cross-functional leadership to provide resolutions to technical and/or personnel issues within projects and report issues to senior management and partners when they will have an impact on budget and/or timeline. Communication skills - must be able to effectively communicate department vision to staff members. Also, must be able to communicate laterally within the quality unit and externally. Solid organization and problem-solving skills. Strong leadership ability. Must be able to provide independent assessment of department with respect to performance. #LI-RS1 #Onsite

Key Responsibilities * Lead and supervise daily execution of tasks to support the published production plan, ensuring completion through Team Leads and Manufacturing Associates. * Provide hands-on leadership, coaching, and feedback to production teams across all shifts. * Ensure robust and timely communication of operational and planning activities. * Support the Line Manager in fulfilling RACI responsibilities (Responsibility, Accountability, Consultation, Information). * Drive, write, and approve new SOPs, batch records, and protocols for equipment and manufacturing processes. * Interface with support groups (Maintenance, Engineering, Quality Assurance/Control, Planning, Warehousing, Process Development) to maintain operational status and support production schedules. * Support quality investigations, continuous improvement, and engineering/maintenance/quality activities. * Initiate and author investigations for process deviations, ensuring timely product release and continuity of operations. * Ensure compliance with cGMP and GDP in all manufacturing activities. * Oversee facility and process maintenance within the area of responsibility. * Collaborate with Development and Engineering for technology transfer of new products/processes. * Ensure training and qualification of operators to support cGMP manufacturing. * Supervise, develop, and evaluate Manufacturing Associates, including Senior OSD MFG Associates. Competencies & Skills * Demonstrated experience leading/supervising exempt and non-exempt employees in a pharmaceutical manufacturing environment, preferably OSD. * Advanced skills in operational planning, personnel management, multitasking, delegation, and relationship building. * Thorough knowledge of cGMP, GDP, and pharmaceutical manufacturing standards. * Basic knowledge of chemistry, biology, and math; mechanical aptitude. * Excellent verbal and written communication skills; detail-oriented. * Ability to interview, hire, and develop personnel. * Team player committed to quality and effective collaboration. * Motivated self-starter; dependable, well-organized, and efficient. * Ability to prioritize tasks and daily workflow; respond quickly to assignments. * Intermediate computer/word processing/spreadsheet skills (e.g., Maximo, SAP, Oracle). * Ability to troubleshoot compliance issues and escalate as needed. Education & Experience * High School Diploma or equivalent required; BS in Engineering, Scientific Discipline, or Business preferred. * 5+ years' experience in pharmaceutical manufacturing or other regulated industry, preferably in OSD. * 3-5 years of supervisory experience preferred. * Experience with commercial and clinical pharmaceutical manufacturing and leadership roles. Physical Requirements * Ability to gown in an aseptic manner for clean room operations. * Ability to operate multiple types of production equipment (e.g., Blenders, HMIs, Tablet presses, Coaters, Wash off lines, Comils). * Ability to lift/move up to 40 lbs; team lift up to 80 lbs. * Ability to stand in steel-toed shoes for a up to 7 hours. * Ability to stand or sit for extended periods (up to 2 hours at a time). * Ability to push/pull equipment or product using a pallet jack. * Must be medically cleared for respirator use (PAPR) and able to properly gown for potent controlled substance formulations. Working Conditions * Available for first shift, with possibility for overtime as necessary. * Must be able to work in both office and manufacturing environments. #LI-AH1

The QC Team Lead will join the microbiology group to provide technical supervision, coordinate and track projects, act as point person on CMC Teams and validation projects. Responsibilities will also include reviewing, reporting test results as related to validation protocols. Direct Support for Method development and optimization for all Microbiology methodology and testing such as Endotoxin, Sterility, Biological Indicators, Microbial Limits, Bioburden. Suggest and implement new technologies and equipment for Microbiological testing. QUALIFICATIONS A four year degree in science, preferably in Biology or Microbiology with minimum 8 years' experience in the pharmaceutical industry Experience with the execution of test methods for sterile and non-sterile drugs, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters Critical thinker, ability to identify issues and work quickly to resolution with minimum supervision Capable of managing/coordinating multiple priorities in a dynamic environment, while maintaining a professional demeanor Understand common microbiological test instrumentation Excellent organizational, planning and scheduling skills Good verbal and written communication skills Good interpersonal skills and ability to work effectively in a team environment. Commitment to continuous improvement in all areas. Ability to work safely; seek out and encourage safe practices Experience with LIMS systems, Trackwise or similar electronic documentation system, SAP MAJOR RESPONSIBILITIES Coordinate and support Tech Services Projects, which include: Method Validations and optimizations New technologies and equipment Assist in the identification of new Microbiology testing technologies and equipment to meet evolving regulatory requirements. Support regulatory audits. Write protocols and execute method verification/validation/qualification/ transfers Write, execute laboratory investigations for out of specifications and out of trend results Point person and Microbiology point person for higher level meetings / projects such as CMC Team support. Write documents (SOPs, specifications, technical reports) Execute, oversee instrument qualification as necessary Implement continuous improvement activities to maximize the resources available Write change controls and work orders for systems and instrumentation changes Review data as needed utilizing LIMS, SAP and SLIM Troubleshooting of technical procedures, methodology and instrumentation Data entry for testing results following GMP regulations Review tests results for other analysts Train new analysts and document training Provide technical support to new analysts Participate in non-routine projects, validations and method development to meet departmental and individual goals Review SOPs, product specifications and controlled forms to comply with USP, EP, JP and CP regulations Maintain the laboratory operations in compliance with industry regulations The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills. #LI-Onsite #LI-RS1

Summary job description: Able to manage a project team within Program Management, ensures project and business management is executed appropriately within the team. With personal responsibility for a portfolio, the role holder is the primary client account and relationship manager for KBI PMO, driving business delivery and exemplary client service to maximum benefit for the company in a sustainable manner. The incumbent may provide training and mentorship to others. Client Management: Responsible for relationship and account management for assigned clients/portfolios Cultivates Client relationship and escalates any Client and team concerns through appropriate leadership channels Manages client expectations efficiently. Maintains strong working relationships with all client representatives. Able to mend and/or develop client relationships Support PM-VOC process and work to identify and address opportunities to improve client service Primary point of contact for all Client communications and coordination of third-party vendor and project needs Client Management: Responsible for relationship and account management for assigned clients/portfolios Cultivates Client relationship and escalates any Client and team concerns through appropriate leadership channels Manages client expectations efficiently. Maintains strong working relationships with all client representatives. Able to mend and/or develop client relationships Support PM-VOC process and work to identify and address opportunities to improve client service Primary point of contact for all Client communications and coordination of third-party vendor and project needs Program Management: Manages project timelines through all phases of development, from project award and kick-off through close-out Ensures that projects are conducted on time, within scope and budget, and meet Client agreed- upon quality standards and expectations through cross-functional project team alignment Develops, manages, and updates project plans in a timely manner. Communicates project status, progress, timelines, changes in schedule, scope changes, technical and/or quality issues to all relevant personnel in the company, and with the Client Schedules, facilitates and documents program related client team meetings, including issuance of agenda, action items, meeting minutes, client communications, etc. Leads cross-functional teams without direct authority by casting a clear vision of project objectives/priorities and motivate the team to achieve them. Able to resolve conflict and foster collaborative partnerships with others to achieve peak performance with some assistance from manager or delegate Analyzes risk, establishes contingency plans and identifies trigger events and responsibility for initiating mitigating action. Gathers stakeholder input and ranks the top project risks in terms of total impact Facilitates discussion regarding portfolio priorities (resolving resource conflicts). Business/Financial Management: Schedules and facilitates strategic client discussions and Joint Steering Committee meetings as required with Senior/Executive Leadership participation and support. Generates meeting minutes and actions items for follow-up Manages the technical and strategic development of the program drawing on relevant Technical leadership from across the organization. This process includes generating and presenting resulting proposals and change orders to the client as appropriate Directs and supports the client with project strategy. Able to suggest and be involved in the implementation of improvements to systems and processes; support PMO with PLF readiness as required Manages all contractual and financial aspects of the project, including finalization of change order and subsequent amendments, monthly budget reviews, forecasting, materials review, assessment of work performed and appropriate Client invoicing and vendor payments Assists Business Development Department in development of proposals as needed PMO Support: Acts as a contributing member of Program Management Organization Manage the site goals and objectives (Balanced Score Card) for self and team Leads or contributes to departmental initiatives as appropriate, including procedure development and improvement Cross-site portfolio leadership OR process ownership; work with PMO and local team to continuously improve PM and project delivery practices. May own a PMO process, responsible for training tools and associated change management Represent or deputize for PMO senior staff as required Other duties as required Minimum Requirements: Minimum bachelor's degree required, preferably in science or related discipline PMP certification (current or planned in the future) Minimum 8 years industry experience, with 5 years or more direct project management experience Line management experience and completion of relevant training an advantage Familiarity with Good Manufacturing Practices Proficiency in English required. Excellent written and oral communication skills. Salary Range: $119,002 - $163,627 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

This position will support and assist in manufacturing pharmaceutical products for commercial and clinical supplies. Key duties include scale-up and transfer of oral solid dosage formulations/processes to the production facility, designing and recommending equipment purchases, and writing and executing equipment specification and commissioning protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes. Develop and implement SOPs in support of new and upgraded processes. Champion projects as they move into and through the manufacturing areas. Provide regular updates to leadership on project status and issues. Essential Functions Troubleshoot and maintain manufacturing systems, processes, and equipment. Support the development or transfer of manufacturing and cleaning processes for the manufacturing area. "Hands-on" ability to install and troubleshoot instrumentation and equipment. Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations) Specify and size manufacturing systems, equipment, and process equipment. Competencies Excellent communication and documentation skills Excellent organizational skills Ability to self-manage and prioritize workload. Ability to react quickly to understand and solve problems. Excellent troubleshooting skills Fosters collaborative relationships within and across groups through influencing and negotiation skills Positive attitude Process Engineer II Basic Qualifications: BS degree in Engineering or technical discipline. 2-5 year of manufacturing experience or technical experience. Preferred Qualification: 2-5 years of OSD pharmaceutical experience or 5 years of pharmaceutical engineering experience. Experience with OSD equipment procurement. Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up. Knowledge of OSD pharmaceutical process and equipment validations. Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc Lead Engineer I Basic Qualifications: BS degree in Engineering or technical discipline. 5+ year of manufacturing experience or technical experience. Preferred Qualification: 5+ years of OSD pharmaceutical experience. Experience with OSD equipment procurement. Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up. Knowledge of OSD pharmaceutical process and equipment validations. Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc Work Environment Work will be split between the contained manufacturing area and the office. Physical Demands Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time Ability to lift/move 40 lbs. overhead. Ability to team lift up to 100 lbs. Must be able to be medically cleared for respirator use (PAPR) Ability to operate different types of production equipment. Ability to gown correctly for clean room manufacturing operations. Ability to stand or sit for extended periods (up to 2 hours at a time). Must be able to work in an office and a manufacturing environment. Travel

Territory Business Manager (TBM) is responsible for selling Alkermes products in the Ohio Valley East territory and supporting promotional efforts. Ideal candidates should be proven sales achievers and live in the territory. This will be done by having thorough product, disease state and market knowledge and sound selling skills. He/she will utilize available resources to help educate healthcare providers. Finally, he/she will use their analytical ability to determine appropriate targets and will use approved resources accordingly. MINIMUM QUALIFICATIONS: BA/BS is required 2+ years successful pharmaceutical/biotech sales experience required Must live within the geography of responsibility Driver's license must be in good standing Must be able to demonstrate or secure appropriate credentialing, as may be required by healthcare providers for physical access to their facilities PREFFERED QUALIFICATIONS: 5+ years successful pharmaceutical/biotech sales experience preferred Specialty sales exp preferred Demonstrated superior organizational and administrative skills Demonstrated past sales performance/success Strong analytical, strategic and influencing skills Some overnight travel may be required The annual base salary for this position ranges from $125k to $155k. In addition, this position offers a performance based sales incentive bonus targeted at forty five thousand dollars annually and eligibility to participate in our long term incentive program. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: ************************************* #LI-Remote The TBM will demonstrate a strong understanding of all aspects of Alkermes products, related disease states and related products in the marketplace The TBM will demonstrate strong selling skills through the use of approved sales aids, approved studies and reprints and through superior communication and listening skills with targeted healthcare providers. He/she will use selling skills that demonstrate competent use of all facets of the Alkermes selling model. He/she will demonstrate an ability to gain agreement for increase product use with appropriate patients from target healthcare providers The TBM will demonstrate strong territory management skills by identifying and calling on appropriate numbers of healthcare provider targets with the required frequency to assure proper usage of Alkermes products. He/she will continually develop, review, update and maintain healthcare provider target lists based on the latest information and data He/she will utilize all available resources and programs (samples, Promotional Speaker Programs, etc.) to increase their business. He/she is prepared to discuss all aspects of territory business with District Business Leader (DBL) at any time The TBM will develop business plans as required by the DBL and will perform all administrative tasks requested in a timely, accurate and truthful manner The TBM will exercise fiscal control of operational expenses (car, gas, office supplies, telephone, postage, lodging, meals, and entertainment) The TBM will demonstrate an ability to work productively with individuals in related positions including but not limited to other representatives, DBL, RMDs, Marketing, and Key Accounts and headquarter personnel The TBM will abide by all Alkermes policies and regulations regarding promotional compliance, and sample accountability compliance

Job Summary: The Manufacturing Science and Technology Engineer will be critical in supporting the manufacturing processes of oral solid dosage forms. This position involves ensuring efficient and compliant production, troubleshooting technical issues, and driving continuous improvement initiatives. Key Responsibilities: Process Support: Provide technical support for the manufacturing of oral solid dosage forms, ensuring processes are efficient, compliant, and meet quality standards. Technology Transfer: Collaborate with cross-functional teams to facilitate the transfer of new processes and products into commercial manufacturing. Troubleshooting: Identify and resolve technical issues related to equipment, processes, and materials to minimize production downtime. Continuous Improvement: Lead and participate in continuous improvement projects to enhance process efficiency, product quality, and cost-effectiveness. Documentation: Author and review technical documents, including batch records, standard operating procedures (SOPs), and technical reports. Compliance: Ensure all manufacturing activities comply with regulatory requirements, Good Manufacturing Practices (GMP), and company policies. Data Analytics: Analyze process data to identify trends, optimize processes, and support decision-making. Collaboration: Work closely with Manufacturing, Quality Assurance, Quality Control, Supply Chain, Process Development and other departments to ensure seamless operations and new improvement/technology installation. Qualifications: Education: Bachelor's degree in Engineering, Pharmaceutical Sciences, or a related field. Experience: Minimum of 5-10 years of experience in pharmaceutical manufacturing, with a technical focus on oral solid dosage forms. Technical Skills: Strong understanding of OSD manufacturing processes, equipment, and technologies. Proficiency in data analysis and process optimization. Familiarity with JMP stats software and coding in JSL, SQL, JAVA, HTML, and/or Python is desired. Problem-Solving: Excellent troubleshooting and problem-solving skills. Communication: Strong written and verbal communication skills. Ability to work effectively with both technical and non-technical teammates. Regulatory Knowledge: Familiarity with GMP, FDA regulations, and other relevant industry standards.

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I: Job Summary Reporting to the CIO, the VP/CISO, will provide strategic and tactical leadership of global information security, disaster recovery, IT risk management, computer systems validation and compliance programs for the enterprise. He/she will establish and evolve the Information Security strategy & roadmaps to meet or exceed all regulatory agencies, government, client partnerships and compliance mandates utilizing a standard risk-based framework that can provide consistent & repeatable practices. This leader will drive the technology and architectural direction including awareness programs that enables effective & lean delivery across the business & IT organizations that achieves cost optimization, quality improvement, bottom-line results while protecting and enabling the business from the evolving security threat landscape. The individual seeking this opportunity will be a strong thought & people leader with excellent communication skills that allow complex security concepts & risk topics be translated to reach diverse levels in the organization at the appropriate pace & speed. This person is the key liaison and therefore must be an excellent collaborator across multiple disciplines including: business stakeholders, executive level technology risk areas, regulatory agencies, compliance partners & the Board of Directors. II: Responsibilities Key Responsibilities: * Sets the vision, strategy & direction for the development & implementation of comprehensive information security, disaster recovery, IT risk management & compliance programs. * Own Board of Directors & Executive level communication and interaction including consulting, understanding of business strategies and translating complex information security threats, risks & programs into achievable, sustainable and innovative technology solutions, capability maturity roadmaps. * Develop and deliver a tiered security dashboard appropriate for each level of cybersecurity governance. Proactively identify problems, measure progress and continuously improve cybersecurity operations. * Create & lead the development of an enterprise Information security awareness program to ensure compliance & that the organization understands the trade-off between risk and return. * Understand and translate the trade-offs required to manage the different levels of risk tolerance and risk exposure across the organization and balance this with risk investments * Leads team to successfully implement security standards, procedures & guidelines for the enterprise as well as reporting security performance against established security metrics. * Ensures and monitors security compliance with industry and government rules and regulations. (e.g., GDPR, HIPAA, ISO 27001, SEC) * Build, develop and retain cybersecurity talent. Support employees in their career development by providing guidance on career paths, opportunities for advancement, and skill development. Develop and implement initiatives to enhance employee engagement, satisfaction, and retention. * Liaise with external agencies, such as law enforcement and other advisory bodies as necessary, to ensure that the organization maintains a strong security posture. * Monitor the external threat environment for emerging threats and advise relevant stakeholders on the appropriate courses of action. * Develop and oversee effective disaster recovery policies and standards to align with enterprise business continuity management program goals. * Set the vision, strategy, and direction for the organization incident response management program. Integrate with the business continuity and crisis management programs. * Provide leadership of the IT Computer Systems Validation (CSV) team responsibilities and accountabilities. * Provide strong leadership through mentoring, career development, teamwork, values, to increase overall employee engagement * Fiscal stewardship in all aspects in all areas of responsibility The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. III: Education, Experience & Skills * Bachelor's degree in IT, business, or related discipline required; Master's degree in Business Administration or related field preferred * Minimum of 15+ years of experience in Information Security * Minimum of 5+ years of experience as Chief Information Security Officer (CISO) serving as an organizations lead security executive * Minimum of 7 - 10 years of experience within the pharmaceutical industry, preferably within pharmaceutical manufacturing facility operations. * Technical understanding of applications, networks, and databases. Understanding of Cloud technologies (e.g. SaaS, PaaS, IaaS) * Experience in the Defense industry preferred. * Industry recognized certifications in the information security and risk management fields with knowledge of national and international regulatory compliances & frameworks. * Deep understanding of CSV guidelines issued by regulatory agencies including FDA and MHRA and standards such as GAMP5. * Well respected team player with excellent skills at building and managing relationships at all levels with a demonstrated ability to manage cross-functional teams. * Visionary leader with strong business acumen and a detailed working knowledge of information security technologies, practices, policies, and their application * A great communicator in both written and oral communication. * A passion for quality and value in all that is delivered. * A no nonsense approach to getting things done. U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from [$267,500 to $323,600]. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: ************************************************************* (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency. ABOUT EMERGENT Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life. Our drive towards this vision informs all of our actions-whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community-we strive every day to achieve this shared goal. WE BELIEVE IN OUR VALUES * Lead with Integrity * We gain trust and confidence through ethics, quality, and compliance excellence * Stand shoulder to shoulder no matter what * We combine our best thinking and communicate openly to support each other. * Own it always * Every person at Emergent is engaged and accountable for delivering on our commitments. * Break through thinking * We take smart risks, pursue innovation and challenge ourselves to constantly improve. * Compete where it counts * We set the right goals and respect each other as we conquer them together.

This position will support and assist in manufacturing pharmaceutical products for commercial and clinical supplies. Key duties include scale-up and transfer of oral solid dosage formulations/processes to the production facility, designing and recommending equipment purchases, and writing and executing equipment specification and commissioning protocols. Troubleshoot automated equipment for pharmaceutical formulation and packaging. Identify and implement process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability. Assure the resolution of deviations, corrective actions, action items from Change Control systems, and any audit non-compliance items. Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes. Develop and implement SOPs in support of new and upgraded processes. Champion projects as they move into and through the manufacturing areas. Provide regular updates to leadership on project status and issues. Essential Functions * Troubleshoot and maintain manufacturing systems, processes, and equipment. * Support the development or transfer of manufacturing and cleaning processes for the manufacturing area. * "Hands-on" ability to install and troubleshoot instrumentation and equipment. * Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations) * Specify and size manufacturing systems, equipment, and process equipment. Competencies * Excellent communication and documentation skills * Excellent organizational skills * Ability to self-manage and prioritize workload. * Ability to react quickly to understand and solve problems. * Excellent troubleshooting skills * Fosters collaborative relationships within and across groups through influencing and negotiation skills * Positive attitude Process Engineer II Basic Qualifications: * BS degree in Engineering or technical discipline. * 2-5 year of manufacturing experience or technical experience. Preferred Qualification: * 2-5 years of OSD pharmaceutical experience or 5 years of pharmaceutical engineering experience. * Experience with OSD equipment procurement. * Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. * Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up. * Knowledge of OSD pharmaceutical process and equipment validations. * Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc Lead Engineer I Basic Qualifications: * BS degree in Engineering or technical discipline. * 5+ year of manufacturing experience or technical experience. Preferred Qualification: * 5+ years of OSD pharmaceutical experience. * Experience with OSD equipment procurement. * Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. * Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up. * Knowledge of OSD pharmaceutical process and equipment validations. * Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc Work Environment Work will be split between the contained manufacturing area and the office. Physical Demands * Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time * Ability to lift/move 40 lbs. overhead. Ability to team lift up to 100 lbs. * Must be able to be medically cleared for respirator use (PAPR) * Ability to operate different types of production equipment. * Ability to gown correctly for clean room manufacturing operations. * Ability to stand or sit for extended periods (up to 2 hours at a time). * Must be able to work in an office and a manufacturing environment. Travel #LI-AH1

Territory Business Manager (TBM) is responsible for maximizing sales of VIVITROL in the Ohio Northwest territory. Ideal candidates will live in Territory and overnight travel is limited. This will be done by having thorough product, disease state and market knowledge and sound selling skills. He/she will utilize available resources to help educate and influence healthcare providers. Finally, he/she will use their analytical ability to assess targets and will use approved resources and efforts accordingly. Minimum Education & Experience Requirements: BA/BS 1-2 years of pharma/biotech/med device/B2B sales experience and/or extensive market experience Must live within the geography of responsibility Driver's license must be in good standing Must be able to demonstrate or secure appropriate credentialing, as may be required by healthcare providers for physical access to their facilities Preferred Skills and Knowledge Requirements: 3+ years successful pharma/biotech sales experience in the Addiction Medicine/Mental Health space Proven track record of success Superior organizational and administrative skills Strong analytical, strategic and influencing skills Some overnight travel may be required The annual base salary for this position ranges from $120k to $155k. In addition, this position offers a performance based sales incentive bonus targeted at forty five thousand dollars annually and eligibility to participate in our long term incentive program. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: ************************************* #LI-TT1 #LI-remote The TBM will demonstrate a strong understanding of all aspects of VIVITROL, alcohol and opioid dependence and related products in the marketplace The TBM will demonstrate strong selling skills through the use of approved sales aids, approved studies and reprints and through superior communication and listening skills with targeted healthcare providers. He/she will use selling skills that demonstrate competent use of all facets of the Alkermes selling model. He/she will demonstrate an ability to gain agreement for increased product use from target healthcare providers The TBM will demonstrate strong territory management skills by identifying and calling on appropriate numbers of healthcare provider targets with the required frequency to assure proper usage of Alkermes products. He/she will continually develop, review, update and maintain healthcare provider target lists based on the latest information and data He/she will utilize all available resources and programs (samples, Speaker Programs, etc.) to increase their business. He/she is prepared to discuss all aspects of territory business with District Business Leader (DBL) at any time The TBM will develop business plans as required by the DBL and will perform all administrative tasks requested in a timely, accurate and truthful manner The TBM will exercise fiscal control of operational expenses (car, gas, office supplies, telephone, postage, lodging, meals and entertainment) The TBM will demonstrate an ability to work productively with individuals in related positions including but not limited to other representatives, DBL, Managed Markets, Marketing, Key Accounts and headquarter personnel The TBM will abide by all Alkermes policies and regulations regarding promotional compliance, and sample accountability compliance

reports to a Supervisor, Manufacturing. This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches. Essential Functions: * Production, bulk packaging, and inspection of pharmaceutical drug formulations * Assisting with facility cleaning and operational maintenance * Cleaning all manufacturing equipment and areas * Assisting with facility and process validations as required * Assisting with environmental and water system monitoring as required * Assisting with RCRA and safety inspections as required * Documenting all work as required by cGMPs and GDPs on a timely basis * Reading and following all Company SOPs and guidelines * Abiding by all safety requirements as defined by the company * Completing other tasks as assigned by supervision Preferred Qualifications: * Basic knowledge of the Scientific Method * Basic math skills including addition, subtraction, multiplication, division, and percentages * Basic knowledge of and adherence to current GMPs and GDPs * Basic knowledge of chemistry and biology * Basic knowledge of HAZCOM, RCRA, and other Safety requirements * Basic level of mechanical aptitude * Good documentation skills * Ability to learn how to operate all types of production equipment (i.e. Blenders, HMIs, Tablet presses, Coaters, Wash off lines, Comils, etc.) * Ability to read, understand, and accurately follow company SOPs and guidelines * Basic knowledge of computer systems (Microsoft Suite, SAP, Veeva Vault, LMS) * Understanding and comprehension of Master Batch Records * Detail-oriented * Willingness to learn new tasks and skills * Ability to work well in a team environment * Ability to respond quickly and execute assignments * Willingness to readily adapt to changing job duties * Positive attitude * Understanding of and promotion of company and customer objectives * Ability to follow all procedures to ensure a high-quality product Education and Experience: Manufacturing Associate I Basic Qualifications: * High School diploma or equivalent Preferred Qualifications: * 0-1 years of experience in a pharmaceutical manufacturing operation, preferably in OSD * A bachelor's degree is preferred; other relevant work experience, education, and training will be considered. Manufacturing Associate II Basic Qualifications * High School diploma or equivalent * 1-3 years of experience in a pharmaceutical manufacturing operation. Preferred Qualifications * 1+ year experience in OSD Manufacturing * Associate degree or higher in a science/technical discipline * Other relative work experience, education, and training will be considered Manufacturing Associate III Basic Qualifications * High School diploma or equivalent * 4-5 years of experience in a pharmaceutical manufacturing operation. Preferred Qualifications * 2-3 year experience in OSD Manufacturing * Associate degree or higher in a science/technical discipline * Other relative work experience, education, and training will be considered Working Conditions: Available for any shift with the possibility for overtime (as necessary) Physical Requirements: * Ability to push and/or pull equipment or product using a pallet jack * Ability to lift/move 40 lbs. overhead. * Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time * Must be able to be medically cleared for respirator use (PAPR) * Ability to operate different types of production equipment. * Ability to gown correctly for clean room manufacturing operations. * Ability to stand or sit for extended periods (up to 4 hours at a time). * Must be able to work in an office and a manufacturing environment.

The Lead Process Equipment Engineer is accountable for driving optimal equipment design, strategic reliability practices, and continuous improvement initiatives to consistently exceed customer expectations. Serves as the SME on process equipment and demonstrates deep functional knowledge of equipment operation across polymer, sterile, and oral solid dosage (OSD) pharmaceutical processes. Spearheads and contributes to continuous improvement projects aligned with commercial and clinical production needs. The role requires troubleshooting automated equipment, implementing equipment improvements, and ensuring compliance with regulatory documentation and operational protocols. This position will collaborate cross-functionally with teams such as, Engineering, Reliability, Manufacturing and Quality to strengthen equipment reliability and proactively mitigate supply chain risk. Job Description: * Serve as Equipment Owner for key manufacturing assets, driving strategic improvements, reliability initiatives, and capacity readiness to meet customer demand. * Lead design, procurement, installation, startup, and commissioning of new process equipment. * Troubleshoot automated equipment for pharmaceutical formulation and packaging. * Partner with manufacturing and maintenance teams on repairs, preventive maintenance programs, and spare parts strategy. * Conduct hands-on training and guidance for the operation of new equipment and processes. * Author high-quality SOPs and technical documentation to maintain GMP compliance in collaboration with appropriate personnel. * Develop and execute engineering studies, change controls, deviation investigations, and commissioning protocols. * Perform risk assessments including FMEA to drive equipment reliability. * Resolve deviations and ensure timely completion of corrective actions and audit responses. * Champion site-level projects, improvement initiatives, and support operational excellence efforts. * Ensure thorough and timely documentation (drawings, specifications, schedules, engineering studies, meeting minutes, etc.) and provide consistent updates to site leadership. * Remain current on industry and FDA engineering standards and trends. * Explore, evaluate, and recommend external technologies to improve current operations or introduce new capabilities. Knowledge/Skills Needed: * Advanced understanding of mechanical and chemical engineering principles applied to complex process systems and equipment. * In-depth knowledge of automated control systems and integration into pharmaceutical manufacturing operations. * Solid knowledge of computer systems and software applications supporting automation and data-driven decisions * Strong capabilities in process equipment design/specification, sizing, statistics, process control and operational risk analysis * Skilled in hands-on instrumentation installation and equipment troubleshooting. * Proven ability to maintain and optimize manufacturing systems, utilities, and process equipment. * Comprehensive knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. * In-depth knowledge of sterile pharmaceutical operations, process equipment and utility qualifications. * Ability to author high-quality technical protocols/reports (Engineering Studies, Validation protocols, summary reports, equipment specifications, and SOPS). * Skilled in navigating matrixed cross-functional teams across engineering, quality, and operations. * Strong presentation abilities with both technical and leadership audiences Personal Attributes Needed: * Exceptional communication, coordination, and organizational skills. * Ability to self-manage and prioritize workload. * Ability to react quickly to understand and solve problems. * Positive attitude and adaptable to changing priorities. * Fosters collaborative relationships within and across and demonstrates ability to work within and contribute to highly effective teams. * Skilled Engineer in design, installation, start-up, and commissioning of typical Pharmaceutical Mechanical Systems. * Effectively manage conflict and differences of opinion * Ability to operate all types of production equipment. Physical Requirements: * Occasional periods of repetitive motion. * Ability to gown in an aseptic manner for clean room operations. * Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. * Ability to operate all types of production equipment * Ability to read, understand, and follow company SOP guidelines. * Steel-toe shoes, scrubs, and other PPE equipment must be worn based on the job being performed. Ability to stand in steel-toed shoes for a 2-3 hours at a time. EDUCATION AND EXPERIENCE Engineer II Basic Qualifications: * BS degree in Engineering or technical discipline. * 6+ years of manufacturing experience or technical experience. Preferred Qualification: * 6+ years of Sterile pharmaceutical experience. * Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations. * Experienced working on (and coordinating) multiple projects in an orderly and efficient manner while consistently meeting established deadlines. * Strong written and verbal communication skills. Ability to work successfully across functions to meet company objectives. * Excellent troubleshooting and problem-solving skills. Lead Engineer I/II Basic Qualifications: * BS degree in Engineering or technical discipline. * 8+ years of manufacturing experience or technical experience. Preferred Qualification: * 8+ years of Sterile pharmaceutical experience. * Experienced working on (and coordinating) multiple projects in an orderly and efficient manner while consistently meeting established deadlines. * Experienced working successfully across functions to meet company objectives. Travel Travel domestic and international ( #LI-AH1

Territory Business Manager (TBM) is responsible for selling Alkermes products in the Youngstown territory and supporting promotional efforts. Ideal candidates should be proven sales achievers and live in Youngstown OH, Kent OH, or Wheeling WV. This will be done by having thorough product, disease state and market knowledge and sound selling skills. He/she will utilize available resources to help educate healthcare providers. Finally, he/she will use their analytical ability to determine appropriate targets and will use approved resources accordingly. MINIMUM QUALIFICATIONS: BA/BS is required 2+ years successful pharmaceutical/biotech sales experience required Must live within the geography of responsibility Driver's license must be in good standing Must be able to demonstrate or secure appropriate credentialing, as may be required by healthcare providers for physical access to their facilities PREFFERED QUALIFICATIONS: 5+ years successful pharmaceutical/biotech sales experience preferred Specialty sales exp preferred Demonstrated superior organizational and administrative skills Demonstrated past sales performance/success Strong analytical, strategic and influencing skills Some overnight travel may be required The annual base salary for this position ranges from $125k to $155k. In addition, this position offers a performance based sales incentive bonus targeted at forty five thousand dollars annually and eligibility to participate in our long term incentive program. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: ************************************* #LI-Remote The TBM will demonstrate a strong understanding of all aspects of Alkermes products, related disease states and related products in the marketplace The TBM will demonstrate strong selling skills through the use of approved sales aids, approved studies and reprints and through superior communication and listening skills with targeted healthcare providers. He/she will use selling skills that demonstrate competent use of all facets of the Alkermes selling model. He/she will demonstrate an ability to gain agreement for increase product use with appropriate patients from target healthcare providers The TBM will demonstrate strong territory management skills by identifying and calling on appropriate numbers of healthcare provider targets with the required frequency to assure proper usage of Alkermes products. He/she will continually develop, review, update and maintain healthcare provider target lists based on the latest information and data He/she will utilize all available resources and programs (samples, Promotional Speaker Programs, etc.) to increase their business. He/she is prepared to discuss all aspects of territory business with District Business Leader (DBL) at any time The TBM will develop business plans as required by the DBL and will perform all administrative tasks requested in a timely, accurate and truthful manner The TBM will exercise fiscal control of operational expenses (car, gas, office supplies, telephone, postage, lodging, meals, and entertainment) The TBM will demonstrate an ability to work productively with individuals in related positions including but not limited to other representatives, DBL, RMDs, Marketing, and Key Accounts and headquarter personnel The TBM will abide by all Alkermes policies and regulations regarding promotional compliance, and sample accountability compliance

would be 9:30 pm to 8:00 am, Monday through Thursday nights. This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches. Essential Functions: The essential functions of this position include: * Production, bulk packaging, and inspection of pharmaceutical drug formulations * Assisting with facility cleaning and operational maintenance * Cleaning all manufacturing equipment and areas * Assisting with facility and process validations as required * Assisting with environmental and water system monitoring as required * Assisting with RCRA and safety inspections as required * Documenting all work as required by cGMPs and GDPs on a timely basis * Reading and following all Company SOPs and guidelines * Abiding by all safety requirements as defined by the company * Completing other tasks as assigned by supervision Preferred Qualifications: * Basic knowledge of the Scientific Method * Basic math skills including addition, subtraction, multiplication, division, and percentages * Basic knowledge of and adherence to current GMPs and GDPs * Basic knowledge of chemistry and biology * Basic knowledge of HAZCOM, RCRA, and other Safety requirements * Basic level of mechanical aptitude * Good documentation skills * Ability to learn how to operate all types of production equipment (i.e. Blenders, HMIs, Tablet presses, Coaters, Wash off lines, Comils, etc.) * Ability to read, understand, and accurately follow company SOPs and guidelines * Basic knowledge of computer systems (Microsoft Suite, SAP, Veeva Vault, LMS) * Understanding and comprehension of Master Batch Records * Detail-oriented * Willingness to learn new tasks and skills * Ability to work well in a team environment * Ability to respond quickly and execute assignments * Willingness to readily adapt to changing job duties * Positive attitude * Understanding of and promotion of company and customer objectives * Ability to follow all procedures to ensure a high-quality product Education and Experience: Manufacturing Associate I Basic Qualifications: * High School diploma or equivalent Preferred Qualifications: * 0-1 years of experience in a pharmaceutical manufacturing operation, preferably in OSD * A bachelor's degree is preferred; other relevant work experience, education, and training will be considered. Manufacturing Associate II Basic Qualifications * High School diploma or equivalent * 1-3 years of experience in a pharmaceutical manufacturing operation. Preferred Qualifications * 1+ year experience in OSD Manufacturing * Associate degree or higher in a science/technical discipline * Other relative work experience, education, and training will be considered Manufacturing Associate III Basic Qualifications * High School diploma or equivalent * 4-5 years of experience in a pharmaceutical manufacturing operation. Preferred Qualifications * 2-3 year experience in OSD Manufacturing * Associate degree or higher in a science/technical discipline * Other relative work experience, education, and training will be considered Working Conditions: Available for any shift with the possibility for overtime (as necessary) Physical Requirements: * Ability to push and/or pull equipment or product using a pallet jack * Ability to lift/move 40 lbs. overhead. * Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time * Must be able to be medically cleared for respirator use (PAPR) * Ability to operate different types of production equipment. * Ability to gown correctly for clean room manufacturing operations. * Ability to stand or sit for extended periods (up to 4 hours at a time). * Must be able to work in an office and a manufacturing environment. #LI-AH1