Tergus Pharma jobs

Job Purpose: This position contributes to the Company's success by providing oversight and execution of method development, validation and formulation support for the development of topical drug products.Summary of Key Responsibilities:• Lead and provide primary oversight for execution of analytical method development, validation and formulation development support• Manage multiple projects simultaneously and communicate with study sponsors and business partners• Review and approve project timelines, cost and resource assumptions• Provide technical expertise for method development/validation efforts of multiple projects and perform high-level review of assay results/interpretation/reports to ensure technical excellence and compliance with appropriate regulatory standards• Coordinate with other departments to optimize resources, streamline laboratory functions and operations and improve quality• Coordinate with Quality Assurance Department to identify, initiate and implement corrective and preventive actions• Approve protocols, instrument qualification protocols, pharmaceutical development reports, SOPs, etc.• Lead, review and trend laboratory investigations• Maintain a GMP-compliant analytical laboratory and safe working environment• Outline career paths for all team members by establishing goals, providing feedback, mentoring and training Required Qualifications and Skills:• B.S. / M.S. in chemistry, pharmaceutical sciences, or related discipline with at least 15 years' related experience, 7-10 years' related experience preferred• Demonstrated management and leadership experience with a specific focus on driving projects to deliverables and growing revenue • Experience with method development for semi-solid products preferred• Experience in topical product development/GMP laboratory setting preferred• CRO experience preferred• Demonstrated experience developing and validating assay methods using HPLC• Working knowledge of regulatory requirements including cGMP, FDA, CFRs, ICH and USP• Technically capable of determining the root cause of a problem, offering potential solutions and working with others to correct the problem• Works toward common goals by supporting, encouraging and sharing information with colleagues, both internal and external• Able to confer with others to reach a resolution, exploring alternatives and positions to attain outcomes that gain the support and acceptance of all parties• Responds to changing needs of the business, and personally identifies and champions new ideas for improvement and growth• Speaks writes, listens and presents information in a logical and articulate manner• Strong technical writing skills• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Packaging Technician I is accountable for driving results in a fast-paced environment by inspecting, labeling and packaging of solid dose and parenteral pharmaceutical products for commercial distribution and clinical trials. The Packaging Technician I will operate inspection and packaging-related processing equipment by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. On-Site Expectations 100% on-site position. 1st Shift: Friday - Sunday, 7:00am - 7:30pm & every other Monday, 7:00am - 3:30pm. Three 12-hour shifts every week plus One 8-hour shift every other week. Responsibilities Documents activities clearly and accurately. Performs basic math calculations. Operates solid dose inspection, labeling and packaging equipment. Operates material handling equipment. Performs in-process checks and component counting. Performs cleaning of rooms, tools and equipment. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications High School Diploma or equivalent with 0 to 2+ years work experience. Mechanical or pharmaceutical experience not required. Mechanical aptitude or work within a regulated environment preferred. Knowledge, Skills, and Abilities Good verbal and written communication and documentation skills required. Good detail orientation and organizational skills required. Good problem-solving and basic trouble-shooting ability required. Ability to perform basic math calculations. Ability to read and comprehend detailed written instructions required. Ability to move materials throughout the facility using appropriate methods and equipment required. Proficiency in basic computing skills required. Awareness of, or prior experience with cGMP practices and procedures preferred. Travel Expectations Less than 5% travel expected. Physical Demands and Work Environment The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Work Standards: Applies GMP/GLP in all areas of responsibility, as appropriate Applies the highest quality standard in all areas of responsibility Demonstrates and promotes the company vision Demonstrates strong client service skills, teamwork, and collaboration Proactively plans and multitasks to maximize productivity Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration Regular attendance and punctuality Support and promote company policies and procedures Proactive and effective escalation to appropriate management Proactively plans and multitasks to maximize productivity of self and direct reports Ensure that the quality policy program is understood, implemented, and maintained; identify, prevent, or correct any departures from the quality system Enforces safety policies across all areas of responsibility Perform laboratory tasks as required to deliver on department objectives Perform all functions in support of and in compliance with all state and federal employment regulations Review and approve quotes as role requires. Identify and take action when pricing is inaccurate Communicates effectively with client staff members Conducts all activities in a safe and efficient manner Performs other duties as assigned Foster a positive and professional work environment Communicate a clear vision and motivate staff to excel Monitor and approve employees' time worked through time-entry system Follow communication plan policy for regular meetings as directed by your business unit Coach, train, and develop others within the group with respect to their personal development to maximize performance Manage workflow and perform daily monitoring to meet customer service needs and KPI Conduct semi-annual performance reviews and interview applicants Perform training record review for direct reports Ensure data integrity record keeping to maintain compliance Confront and address problems, concerns and performance issues in real time Expand self-awareness and develop leadership skills as defined; attend applicable leadership training based on identified needs Effectively delegate and exercise accountability of self and others Perform succession planning in preparation for growth of team and self Qualifications Bachelor's degree in chemistry, biology, biochemistry or related degree concentration. 6+ years of microbiology lab experience, including environmental monitoring in a GMP-regulated setting. 6+ years of experience leading technical or laboratory teams. Strong knowledge of microbiological testing, EM protocols, and lab compliance standards. Proven ability to coach staff, manage lab operations, and drive team performance. Additional Information Position is full-time, Monday - Friday 8:00am - 5:00pm . Candidates currently living within a commutable distance of Cary, NC are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

The Sales Representative implements tactics as defined by the Marketing and Sales plans for the Neurology Team. They deliver balanced sales presentations to a defined list of current and prospective customers with a defined frequency. In the assigned territory, the Sales Representative will utilize all marketing and selling materials designed for a respective audience. They engage in effective business planning, calling on customers including a variety of healthcare practitioners. The Sales Representative will plan and organize activities to ensure regular and consistent coverage of the territory according to a plan of action. Increased product sales will result from the Sales Representative's effective efforts. Administration of territory information and compliance to reporting and regulatory requirements is imperative. Participation in training, conference calls and meetings is essential. Essential Functions: * Achieve all product sales performance goals and objectives for geographical assignment (territory). * Distribute samples and record sample transactions in accordance with Company Policy and PDMA guidelines. * Develop comprehensive and accurate sales presentations using all approved marketing and selling materials. * Maintain proficient knowledge of promoted product disease states and indications. * Deliver proficient sales presentations to a defined list of current and prospective customers with a frequency based on assigned call goals. * Implement the Amneal selling model and process principles, including the DiSC personality profile when engaging with customers. * Complete pre and post call analysis which positively impacts customer interactions. * Regularly review and analyze all available sales data and utilize developmental budget funds * Adhere to all compliance policies and guidelines. * Develop a daily call schedule to ensure efficient and comprehensive coverage of territory. * Complete administrative reports and meet related deadlines. * Ensure proper safeguarding and care for company assets (laptop, iPad, fleet vehicle. etc.). * Enter calls immediately into Veeva System via iPad and check/respond to email daily. Additional Responsibilities: * Adherence to all company and compliance policies, guidelines and reporting requirements

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Manager of Planning and Scheduling is a cross-functional leadership role responsible for driving all aspects of manufacturing planning, scheduling, capacity planning, inventory readiness, and seamless material availability to enable on time manufacturing execution. This position combines the strategic planning and leadership to enable execution of the production schedule on time and through release (end-to-end) of each batch, in compliance with GMPs. The Manager leads the efforts for scheduling and planning of manufacturing, staff development, provides technical guidance, and fosters a culture of accountability and continuous improvement. This role requires cross functional leadership and strong expertise in SAP (MM/IM/WM), supplier negotiations, and material flow management, with a proven ability to manage multi-priorities while coaching and developing a high-performing team. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Leadership & People Development Lead, coach, train, and develop planning and scheduling staff to build a high-performance team. Manage day-to-day operations, ensuring staff are fully trained, engaged, and aligned with business needs and objectives. Foster a culture of continuous improvement, accountability, and internal customer value. Represent the department in meetings and regulatory inspections, promoting audit readiness. Planning and Scheduling Execution Lead planning and scheduling strategies and collaborate with purchasing and logistics to ensure material and resources are available to execute the production schedule without delay. Manage supplier qualification, performance, and compliance with Quality and Regulatory expectations. Place and manage purchase orders aligned with production forecasts and schedules. Monitor inventory and material flow across sites to ensure on-time availability, risk mitigation, and supply continuity. Oversee batch prep and staging (Kitting of materials for a batch), transfers, and disposal of materials in alignment with SOPs. Prepare and present planning and scheduling metrics, inventory reports and capacity analysis for business and client needs. Prepare and measure capacity within the manufacturing operations. Considering each fill line, compounding suites and equipment to maximize compliance, output, and resources. Systems & Process Management Serve as a subject matter expert in SAP (MM/IM/WM), ensuring accuracy in establishing minimum inventory needs, inventory availability, and batch readiness management and postproduction transactions. Drive master data accuracy, standardization, and system improvements across sites. Collaborate with Manufacturing, Purchasing, Quality, Laboratories, Engineering, Project Management and Finance to execute Plan-to-Manufacture (P2M) and Procure-to-Order (P2O) processes. Identify and resolve bottlenecks, implementing corrective and preventive actions to enhance operational efficiency. Client & Cross-Functional Engagement Support client visits, audits, and inquiries, ensuring fulfillment of requests and building credibility and trust. Communicate effectively with internal and external stakeholders regarding material availability, supply risks, and alternative solutions. Build and maintain strong supplier and internal customer relationships to drive business success. Qualifications Bachelor's degree in Business, Supply Chain, Operations Management, Engineering, or related fields (required). APICS/CPIM certification a plus. 6+ years of supply chain, procurement, or materials management experience in a pharmaceutical, biotech, or CDMO environment. Minimum 2+ years of management/supervisory experience. Prior GMP or regulated business experience required; CDMO experience preferred. Knowledge, Skills, and Abilities Strong leadership skills with proven ability to build, develop, and retain high-performing teams. Expertise in SAP modules or other Enterprise systems: MM, IM, WM; deep understanding of P2P, P2M, and P2O processes. Strong supplier negotiation and relationship management skills across domestic and international markets. Ability to balance cost savings, supply reliability, and compliance. Demonstrated ability to lead cross-functional projects and continuous improvement initiatives. Excellent communication, presentation, and relationship-building skills across all organizational levels. Proficiency in MS Office Suite (Word, Excel, Outlook). Strong problem-solving, time management, and decision-making skills. Travel Expectations Up to 20% domestic travel. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Metrologist is a team player working in a fast-paced environment by performing calibration and preventive maintenance (PM) tasks of instruments including pressure, temperature, relative humidity, volumetric and mass in pharmaceutical manufacturing and laboratory environments. The ideal candidate will have a basic understanding of calibration and instrumentation and the use of computerized equipment and software to perform testing functions. On-Site Expectations 100% on-site position. 2nd Shift: Monday - Friday, 3:00pm - 11:30pm. Responsibilities Performs calibrations, PMs and repair on a variety of instrumentation with supervision. Utilizes several database systems. Maintains all logs and required documentation. Reads and follows Standard Operating Procedures (SOP's). Provide excellent customer service Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications High School diploma or equivalent with 2+ years of relevant experience or an associate's degree with at least 1 year of relevant experience. Knowledge, Skills, and Abilities Basic understanding of circuits, components, equipment and instrumentation for manufacturing and laboratories. Excellent mechanical skills. Excellent verbal and written communication skills. Excellent organizational skills. Reliable, self-motivated, and a team player. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Eurofins CRL Cosmetics, LLC seeks a Consulting Board-Certified Pediatrician to serve as a Principal Investigator for Clinical Studies of Personal Care and Cosmetic Products in Winston-Salem NC. This Consultants position allows professionals to contribute their expertise while supporting the Eurofins CRL mission of ensuring consumer product safety all for families. This Consultant position involves the conduct of PI responsibilities such as: * Reviewing study protocols, amendments and completed study reports. * Documenting observations/results of in lab conducted subject dermal evaluations at protocol specified timepoints. * Managing any noted deviations or adverse events. All other PI responsibilities will be conducted by our highly qualified lab team. Qualifications Time Requirements: * Consist of 2-6 studies per year. Normally 1 to 2 days in the lab per study. (4-8hrs/day) * The amount of time in the lab depends on the number of subjects needing to be seen. * Remainder of work can be done remote from home or the office. Dermal Evaluations: * Erythema * Edema * Dryness Additional Information Compensation: As this role is limited PI responsibility, the compensation reflects the time and task. * On-site time: $120/hr. * Remote Signatures: $150 each Eurofins USA Consumer Product Testing is a Disabled and Veteran Equal Employment Opportunity employer.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Scientist I (QC Chemistry) is accountable for driving results in a fast-paced environment by performing analytical routine testing in support of pharmaceutical product development or pharmaceutical manufacturing. For this Scientist I (Chemistry) position, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company). On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities Performs one or more of the following techniques: assays, potencies, pH, TOC, moisture content, identification, particle size, and various other wet chemistry and instrument-based measurements. Evaluates and interprets generated data. Analyzes information for technical correctness and accuracy. Understands the theoretical basis of methods/experiments. Performs technical review of common laboratory data. Maintains laboratory stock of reagents, clean glassware, and removes expired solutions. Solves problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Maintains working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks. Assists in removal of hazardous waste, routine equipment cleaning and restocking of consumable products and reagents. Effectively uses various laboratory software packages (Empower3, ProCal, Master Control, ELN, etc.). Maintains a safe, clean, and organized work environment free of safety hazards. Safely handles potent compounds. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications Bachelor's degree in Chemistry, Biochemistry, or a related field with course work in Chemistry with 2+ years related work experience. Or Associates degree in Chemistry or related field with 6+ years related experience. Knowledge, Skills, and Abilities Good verbal and written communication and documentation skills required. Good detail orientation and organizational skills required. Good problem-solving and basic trouble-shooting ability required. Strong knowledge of Laboratory equipment and safety required. Strong knowledge of Laboratory Documentation is required. Working knowledge of cGMP in a pharmaceutical or regulated environment preferred. Proficiency with Microsoft Office (Word, Excel, PowerPoint) required. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is occasionally required to walk, sit, climb, or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, half face and full-face respirator, lab coats, full protective body coverings, various types of gloves, etc.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Manager, Laboratory Operations - Biologics is accountable for driving results in a fast-paced environment by providing strategic, technical, and operational leadership for the biologics department of Bioseparations & Mass Spectrometry within Laboratory Operations. This position requires a balance of scientific expertise, business acumen, and customer focus to ensure high-quality services, efficient execution, and sustained growth. The ideal candidate will be a collaborative leader with a proven track record in biologics development and testing, who thrives in a client-driven CDMO environment. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities Acts as the primary point of contact for key biologics clients, ensuring exceptional customer service and responsiveness. Oversee analytical services supporting biologics and other large molecules, including bioseparations using a variety of chromatographic and electrophoretic methodologies, characterization, release, stability testing, and other specialty studies. Extensive experience with mass spectrometry as applied to biologics, including method development, characterization, troubleshooting of instrumentation, data interpretation, and application of advanced analytical techniques to complex biologics. Translate client needs into actionable project plans while balancing scientific rigor with business requirements. Serve as subject matter expert in Biologics for internal and external stakeholders. Ensure projects are executed on time, on budget, and to the highest quality standards. Lead capacity planning, resource allocation, and prioritization of biologics projects across the analytical team. Drive operational efficiency, technical advancements, and laboratory innovation. Foster a culture of quality, compliance, scientific excellence, and continuous improvement. Drive professional development, technical training, and succession planning for staff. Attract, develop, and retain a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management. Promote a collaborative and innovative environment that encourages problem-solving and accountability. Ensure adherence to SOPs, training, and other regulatory requirements. Stays current on industry and regulatory laboratory trends and adapts the quality systems, practices, and procedures, as necessary. Qualifications Doctorate degree with 8+ years, or Master's degree with 10+ years, or Bachelor's degree with 12+ years of related experience in Chemistry, Biochemistry, or related field. 2+ years of previous supervisory experience. Experience in development, validation, and verification of analytical testing methods. Experience with inspections/audits by regulatory agencies and clients. Previous experience within CMO, or CDMO preferred. Previous experience in pharmaceutical GMP environment required. Knowledge, Skills, and Abilities Proven experience in CDMO/CMO environment desired. Thorough knowledge of GMP requirements and regulatory compliance. Understanding of biologics modalities (mAbs, proteins, cell & gene therapies, etc.) and analytical methodology (HPLC/UPLC, electrophoresis, mass spectrometry, AUC, UV/Vis, potency assays, etc.). Demonstrated success in building and leading teams, driving operational performance and achieving business growth. Excellent communication and interpersonal skills with ability to effectively represent the organization holistically to external clients. Demonstrated business acumen with ability to balance scientific excellence and commercial priorities. Demonstrated experience representing analytical or biologics operations during regulatory inspections. Strong organization and management skills required. Record of accomplishment in change management and proven ability to build teams. Self-motivated with high-energy and an entrepreneurial team spirit, willing to get “hands on” to build the business. Excellent written and verbal communications and presentation skills required. Strong skills with Microsoft Office (Word, Excel, and PowerPoint) required. Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you're looking for a rewarding career, a place to call home, apply with us today! Job Description Senior Laboratory Technician responsibilities include, but are not limited to, the following: * Performs sample preparation on tobacco products using smoking machine and wet chemistry techniques; provides support to analytical chemists * Performs some less complex routine analyses in support of product assessment and quality control on tobacco products utilizing Liquid Chromatography, and/or multiple wet chemistry techniques * Accurately documents result in notebooks and laboratory LIMS, in compliance with good documentation practices * Performs instrument calibration, and recognizes errors * Adheres to highest quality standards; ensures compliance with quality system requirements * Communicates effectively with client staff members and co-workers Qualifications The ideal candidate would possess: * Strong computer, scientific, and organizational skills * Excellent communication (oral and written) and attention to detail * Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude * Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies * At least one-year related laboratory or quality control experience; familiarity with standard lab concepts, practices, and procedures Basic Minimum Qualifications: * High school diploma or equivalent * Authorization to work in the United States indefinitely without restriction or sponsorship Additional Information Position is full-time, Mon-Fri 8:00am-5:00pm. Candidates currently living within a commutable distance of Winston-Salemm, NC are encouraged to apply. * Excellent full time benefits including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Sr. Supervisor, Metrology is accountable for driving results in a fast-paced environment by supporting general pharmaceutical metrology activities. Specific responsibilities include reviewing SOP's, composing/revising SOP's and metrology master plans; supporting facility, utility, manufacturing equipment, and laboratory instrument metrology efforts; conducting reviews of metrology documentation such as metrology plans, system/functional requirements, protocols and summary reports. The position requires strong leadership behaviors and the ability to train and mentor staff. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Leads the metrology department to optimize the qualification of equipment and systems. Exercises judgment within defined procedures and practices to determine appropriate action. Maintains all documentation pertaining to qualification and metrology. Develops procedures and/or protocols. Leads investigations as needed. Develops team metrics, and ensures monthly goals are met. Serves as information resource for other metrology personnel, contractors and vendors. Executes and oversees procedures and/or protocols. Drafts and approves department SOP's and training modules. Reviews, composes/revises SOP's Owns the laboratory equipment requalification program and compliance to the program. Acts as a certified trainer for applicable training Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Represent Alcami in audits (both client and regulatory) regarding metrology related questions. Other duties as assigned. Qualifications Requires a related Bachelor's degree with 5+years of relevant experience within the Pharmaceutical Industry. Must have at least 3+ years of experience in supervisory roles. Knowledge, Skills, and Abilities Excellent knowledge of quality assurance reviews of metrology and validations documentation. cGMP training and excellent understanding of requirements. Excellent knowledge of pharmaceutical GMP environment. Excellent understanding of and ability to utilize Pro Cal. Excellent verbal and written communication skills. Excellent mechanical skills. Strong understanding of Excel. Strong understanding of Word. Strong positive team player. Ability to train and mentor others. Ability to listen and respond well to external customers, partners, and colleagues at all levels. Highly goal and result oriented. Prioritizes tasks according to business objectives and can pursue several objectives simultaneously. Can work independently with a high degree of self-motivation. Knows how to obtain support from different collaborations. Tackles problems with enthusiasm and curiosity. Treats colleagues at all levels with respect. Very effective listening skills with the ability to hear attentively and process information correctly. Travel Expectations Up to 10% travel expected. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Director, Information Security & End User Computing (EUC) is a senior IT leader responsible for safeguarding Alcami's information assets, overseeing enterprise security programs, and managing all end-user computing services and support functions. This role leads teams across security operations, infrastructure protection, and EUC support, ensuring reliable, secure, and high-quality technology experiences for all employees. The Director is expected to coach, develop, and grow technical talent while driving operational excellence, resilience, and continuous improvement across their areas of responsibility. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities Information Security Leadership Serve as Alcami's Information Systems Security Officer (ISSO) and lead enterprise security governance, assessments, and compliance programs. Manage security risk assessments across applications, cloud environments, and infrastructure. Maintain continuous security monitoring, vulnerability management, and incident response readiness. Oversee documentation and controls aligned with NIST RMF, ISO standards, and applicable regulatory frameworks. Partner closely with the CIO, CISO (if applicable), and other business leaders to strengthen Alcami's security posture. Contribute to COOP/DR strategy and ensure security considerations are embedded across all technology operations. End User Computing (EUC) Leadership Lead the EUC function, including Service Desk, desktop support, endpoint management, mobile devices, and collaboration tools. Oversee deployment, configuration, and lifecycle management of laptops, desktops, mobile devices, peripherals, printers, and standard office applications. Ensure timely, high-quality support for all users, with strong SLAs, KPI tracking, and a culture of ownership. Manage endpoint security controls, patching, and compliance across all devices. Drive standardization of images, device configurations, and application delivery. Strengthen ITIL-aligned service processes, change management discipline, and incident/problem management routines. Oversee Microsoft 365 administration in partnership with relevant infrastructure teams. People Leadership & Operations Recruit, develop, mentor, and retain high-performing teams across Security and EUC. Establish a culture of accountability, continuous learning, partnership, and proactive communication. Build operational roadmaps, establish strategic objectives, and manage departmental performance against goals. Develop and manage annual budgets for Security and EUC. Represent IT in cross-functional meetings and partner with customers across the organization to drive value. Continuous Improvement & Technical Leadership Drive innovation, process optimization, and automation across both Security and EUC operations. Provide technical guidance for troubleshooting complex security, infrastructure, and EUC issues. Maintain strong knowledge of emerging technologies, vulnerabilities, and best practices. Support audits, client assessments, and regulatory inspections. Qualifications Bachelor's degree in a related field; equivalent experience considered. 12+ years of experience in IT, including significant experience in Information Security and EUC operations. 6+ years of leadership experience managing technical teams. CISSP or equivalent security certification preferred. Deep expertise in security architecture, risk assessment, vulnerability management, and cloud security. Experience managing enterprise EUC environments, endpoint security, and Microsoft 365. Strong communication, customer engagement, and cross-functional collaboration skills. Proven ability to build high-performing teams and drive operational excellence. The ability to obtain and maintain a U.S. government issued security clearance is required. U.S. citizenship is required, as only U.S. citizens are eligible for a security clearance. Knowledge, Skills, and Abilities Must have experience with the following: Cloud expertise, and the ability to teach Mobile experience SCADA, infrastructure protection, and/or engineering experience Must be eligible to obtain a sensitive clearance - Position of Public Trust - and may be required to obtain a higher security clearance. Ability to manage responsibility for security assessments of a variety of applications or domains, to include cloud computing, and to manage several project/initiatives of large size, complexity, and risk. Demonstrated proficiency in implementing security controls, conducting risk assessments, and documenting compliance measures based on NIST RMF and ISO standards to meet organizational and regulatory requirements. Demonstrated proficiency in successfully evaluating and supporting documentation, validation, and accreditation processes necessary to assure that new and existing information technology (IT) systems meet the organization's information assurance (IA) and security requirements. Demonstrated proficiency in ensuring appropriate treatment of risk, compliance, and assurance from internal and external perspectives. Demonstrated ability to support development of actionable security blueprints, principles, models, designs, standards, and guidelines to ensure enterprise IT architecture and support is consistent, usable, secure and adds value to the business. Experience with network and vulnerability scanning tools and technologies to interrogate systems for configuration and status. In-depth understanding of security architecture principles and best practices to design, implement, and maintain secure IT infrastructures in alignment with corporate policies and compliance standards. Experience in computer forensic techniques. Excellent technical knowledge of mainstream security technologies and understands operation of them, such as network security appliances, Intrusion Detection Policies, identity and access management (IAM) systems, anti-malware solutions, antivirus solutions, automated policy compliance tools, desktop security tools, CASB, Email Protection, DNS filtering, IPS/IDS, XDR, and Vulnerability Management. Expert knowledge of Microsoft product-based systems. Strong knowledge of Service Now administration. Strong knowledge of application deployment, OS deployment, OS patching, and inventory management. Demonstrated experience in advanced troubleshooting of computer hardware and software. Excellent communication and interpersonal skills. Strong technical skills for area managing. Strong business acumen. Strong understanding of company SOPs, and regulatory guidance documents. Strong knowledge of safety procedures and quality compliance for assigned area. Strong knowledge of cGMP requirements. Strong experience with client audits. Excellent analytical and problem-solving skill, with the ability to think strategically. Strong attention to detail as well as time and resource management. Good presentation skills. Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction. Promote a safe environment for work. Comply with the general policy of the company. High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction. Ability to develop and manage a high-performance team focused on quality, accountability, and meeting and exceeding expectations. Communicate well orally both for internal customers and team members as well as external customers. Ability to write reports and business correspondence. Ability to listen and respond well to external customers, partners, and colleagues at all levels. Highly goal and result oriented. Prioritizes tasks according to business objectives and can pursue several objectives simultaneously. Can work independently with a high degree of self-motivation. Knows how to obtain support from different collaborations. Tackles problems with enthusiasm and curiosity. Treats colleagues at all levels with respect. Very effective listening skills with the ability to hear attentively and process information correctly. Travel Expectations Up to 25% travel expected including training. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description * Applies GMP/GLP in all areas of responsibility, as appropriate * Applies the highest quality standard in all areas of responsibility * Demonstrates and promotes the company vision * Demonstrates strong client service skills, teamwork, and collaboration * Proactively plans and multitasks to maximize productivity * Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration * Regular attendance and punctuality * Applies 17025 compliance standards in all areas of responsibility, as appropriate * Performs complex analyses and non-routine testing in support of product assessment and quality control on products utilizing one or more analytical techniques (e.g., HPLC, GC, GC-MS, ICP, mass spectrometry, smoking machines, or other special purpose equipment and/or multiple wet chemistry and physical techniques.) * Operates and maintains job-related equipment as required * Performs advanced troubleshooting of laboratory equipment * Performs supporting verification, calibration, and maintenance tasks (e.g., balance calibration and pipette verifications) * Performs laboratory tasks as assigned following supervisor direction, SOPs, WI, and other documentation * Assists other staff in the edits and updates of SOPs, WI, and other documentation * Follows all Good Documentation Practices appropriately, including digital platforms * Maintains working areas appropriately (cleaning, disinfecting, etc.) * Possesses strong organizational skills * Provides clear feedback * Keeps accurate records, follows instructions, and complies with company policies * Proactively checks and stays current with all training across multiple learning platforms * Provides instruction/training to new staff * Recognizes errors, identifies root causes, and applies process improvements * Provides analysis support for method validation as needed * Evaluates, reviews, and approves data by other analysts * Independently drafts, edits, and updates SOPs, WI, and other documentation * Performs all testing with good dexterity, good laboratory techniques, and a high degree of accuracy and precision * Makes recommendations for technical improvements, as needed * Assists in Method Development and executes method validation protocols * Assist in method transfer from the MDV group * Write validation protocols and reports * Communicates effectively with client staff members * Conducts all activities in a safe and efficient manner * Performs other duties as assigned Qualifications * Bachelor's degree in Chemistry, Biology, or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major) * 7+ years of related experience Additional Information * Position is full-time, Monday - Friday 8am to 5 pm * Ability to work overtime as required. * Tasks require repetitive motion and standing for long periods of time. * May be required to respond to off-shift operational issues. * Candidates currently living within a commutable distance of Winston-Salem, NC are encouraged to apply. * Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options * Life and disability insurance * 401(k) with company match * Paid vacation and holidays * #LI-EB1 * Authorization to work in the United States indefinitely without restriction or sponsorship Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Process Engineer's responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and writing reports and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices. On-Site Expectations 100% on-site position. 1st Shift: Monday - Friday, 8:00am - 5:00pm. Responsibilities Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects. Writes Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc. Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed. Author manufacturing investigations and complete CAPA assignments. Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols. Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products. Interact with clients during routinely scheduled project meetings. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications Bachelor's degree in Engineering, Pharmacy, Chemistry, or related field required. Minimum 2 years of experience of technical support and technical transfer in a sterile pharmaceutical manufacturing environment. Knowledge, Skills, and Abilities Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required. Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes. Proficiency with Microsoft office (Word, Excel, Outlook) required. Ability to interact with internal stakeholders and external customers. Working knowledge of EU regulations is preferred. Physical Demands and Work Environment The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes, or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places, risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard Additionally, the employee may be required to operate an industrial vehicle.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The SAP ABAP Developer will be responsible for designing, developing, testing, and supporting custom solutions and enhancements across SAP environments. This role combines strong expertise in traditional ABAP development (ECC and S/4HANA) with modern, cloud-native capabilities on SAP BTP. The developer will work closely with functional consultants, business analysts, and cross-functional stakeholders to translate requirements into robust, compliant, and scalable solutions. This is a hands-on technical role with broad impact-contributing to innovation, automation, and continuous improvement in a regulated pharmaceutical manufacturing environment. On-Site Expectations 100% on-site 1st Shift: Monday - Friday, 8:30am - 5:30pm. Responsibilities ABAP Development: Design, develop, and maintain custom ABAP objects: Design, develop, and implement custom ABAP programs, enhancements, and interfaces (RICEFW: Reports, Interfaces, Conversions, Enhancements, Forms, Workflows) Classical/Interactive and ALV Reports BAPIs, BADIs, User Exits, Enhancements (Implicit/Explicit) Smart Forms, Adobe Forms, SAPscript OO ABAP (Object-Oriented ABAP) and Function Modules Develop and support interfaces using IDocs, RFCs, Web Services. Implement S/4HANA-specific features such as: Core Data Services (CDS) Views ABAP Managed Database Procedures (AMDP) OData services for SAP Fiori apps. Perform code optimization, debugging, and performance tuning. Collaborate with functional consultants to gather business requirements and translate them into technical designs. SAP BTP (Business Technology Platform) Development Design and implement cloud-based applications and extensions using SAP BTP services (e.g., SAP Extension Suite, Integration Suite). Develop Fiori applications and deploy them on BTP. Create and manage OData APIs, REST services, and event-driven integrations. Work with CAP (Cloud Application Programming) model for BTP applications. Implement security and authentication mechanisms (OAuth, SAML, XSUAA) within BTP applications. Build and maintain CI/CD pipelines and manage deployments to BTP environments. Integration & Collaboration: Integrate SAP on-premise systems (ECC/S4) with BTP using Cloud Connector or APIs. Work closely with cross-functional teams (Basis, Security, Functional, Integration) to ensure end-to-end solution integrity. Support system upgrades, patches, and migrations. Quality & Standards: Follow SAP development best practices, coding standards, and performance optimization guidelines. Document technical specifications, solution designs, and deployment procedures. Participate in peer code reviews. Author Change controls Other duties as assigned. Qualifications Bachelor's degree in Computer Science, Information Technology, Engineering, or related field (or equivalent professional experience). SAP ABAP or SAP BTP developer certification a plus. 5+ years of SAP ABAP development experience (ECC or S/4HANA). 2+ years of SAP BTP development experience, including building applications or extensions. Industry experience in pharmaceuticals, life sciences, or manufacturing. Knowledge, Skills, and Abilities Experience with at least one full SAP implementation or major upgrade. Experience with Agile/Scrum methodologies. Strong ABAP programming expertise: Reports, BAPIs, BADIs, Enhancements, Forms. Experience in modules like MM, SD, PLM, PP, PS, TM, FICO. Hands-on experience with S/4HANA ABAP: CDS Views, AMDP, OData service creation. Proficiency with SAP BTP services: Extension Suite, Integration Suite, CAP, SAPUI5/Fiori. Familiarity with SAP Cloud Connector and API Management. Knowledge of Git-based source control, CI/CD tools, and DevOps practices. Understanding of REST APIs, JSON, and modern web development concepts. Strong communication, stakeholder engagement, and project management skills. Strategic thinking and commercial acumen in supplier management. Strong analytical skills with the ability to interpret complex data and drive operational decisions. Excellent communication and organizational skills; strong attention to detail and compliance. Deep understanding of GMP/GDP, FDA, and international regulatory expectations. Strong sense of urgency and attention to detail. Extremely high standards of excellence. Ability to handle multiple and sometimes competing priorities. Travel Expectations Up to 20% travel expected excluding training which will require travel. Physical Demands and Work Environment The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

Job Purpose: Responsibilities include providing pro-active administrative and technical leadership to facility, utilities, calibration, space planning, EH&S, security, and related projects. Fosters innovation and executes strategies to meet site objectives, ensure reliability, and regulatory compliance including preventative and predictive maintenance programs as well as site capital (CAPEX) budget. This department has the overall responsibility for the management and supervision of all facilities, utilities, maintenance and calibration activities for the Tergus Pharma Commercial Site. This includes, but not limited to the areas of building utilities, grounds and building maintenance, as well as maintenance system improvements. Summary of Key Responsibilities: • Plans, organizes and directs the Engineering and Maintenance activities and programs relating to the reliability and improvement of the site, including the evaluation and purchase of new equipment, improvement and modification/renovation of existing equipment and facilities. Directs and approves maintenance activities to ensure the maintenance of Tergus Pharma Commercial facilities in a manner consistent with established long- and short-term objectives. • Takes ownership for, develops and/or continually improves maintenance programs (PM, Work Order System, etc.) • Assure compliance with all governmental, state and local regulations. • Drive a culture of safety ownership, with a continuous focus on improving safe work practices Work to eliminate safety hazards, respond quickly to any safety issues, and ensure proper maintenance of plant equipment for continued safe operation • Administers personnel development programs within Maintenance. Conducts periodic performance reviews, trains and prepares for orderly succession of positions. Facilitates the development and continuity of effective teamwork toward achievement of site goals. Develops climate conducive to trust, open communications, mutual goal setting, and recognition. • Assists, plans, develop and implements Maintenance strategies required for meeting company objectives. • Responsible for developing, managing and implementing the Engineering and Maintenance budget. • Identifies and implements improvement projects to reduce manufacturing costs. • Assures the participation of Maintenance in the selection, testing and evaluation of new processes and equipment. Provides assistance and Maintenance expertise in the start-up and validation of systems and equipment. • Assists with the selection, purchase and installation of new equipment, modification of existing equipment, and the removal and disposition of obsolete equipment. • Directs establishment and monitors general and preventative maintenance programs developed to insure timely and efficient repair and maintenance of machinery, equipment, facilities and support systems through reporting personnel responsible for implementation of established programs. Directs responsible subordinate personnel in establishment and adherence to long-range maintenance and planning goals. • Maintains accurate working knowledge of governmental/regulatory requirements as related to equipment including EPA, OSHA, and the FDA. Monitors and ensures company compliance with regulatory standards. Accompanies agency representative or inspector as required. Responds to infractions. • Responsible for developing and managing the space planning for the facility. • Directs the calibration and preventive maintenance programs and ensures a timely completion of the programs. • Manages the security team/systems of the site. • Other related duties as assigned to meet departmental and Tergus Pharma objectives. • Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies. • Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. Required Qualifications and Skills: • Bachelor's Degree in Mechanical, Electrical, or Chemical Engineering, is required, with a minimum of 10 years of broad-based technical management, preferably in a pharmaceutical manufacturing environment. Also, a minimum of 5 years of management experience required for this position. • Certification of Reliability Engineering preferred. • Knowledge of manufacturing, filling and packaging equipment and process of topical ointments/creams/solutions preferred. • Expertise in Facilities, Maintenance, Calibration, Utilities management, Security management, and space planning experience is required. • Expertise in capital budget (CAPEX) preparation and control is required. • Demonstrated positive results in progressive positions of authority, including a record of success in a cGMP pharmaceutical manufacturing environment.

The Associate Sales Representative provides short-term territory coverage under the direction of a Region Business Manager. This role involves planning and executing sales activities, delivering presentations to healthcare professionals, and using approved marketing materials to drive product awareness and sales. The position requires frequent travel (80%+), including overnight stays, and candidates must live near a major airport. Responsibilities also include maintaining compliance with reporting and regulatory standards, participating in training, and supporting business planning efforts. Essential Functions: * Under close supervision of the RBM, achieve all territory management, call activity goals and performance objectives for geographical assignment(s) including but not limited to call activity, sample and resource utilization, target reach and frequency, and sales performance. * Under close supervision of the RBM, maintain proficient knowledge of promoted product disease states and indications. * Deliver proficient sales presentations to a defined list of current and prospective customers with a frequency based on assigned call goals. Implement the Amneal selling model and process principles, including the DiSC personality profile when engaging with customers. * Complete pre and post call analysis which positively impacts customer interactions. * Regularly review and analyze all available sales data and utilize developmental budget funds * Under close supervision of the RBM, adhere to all compliance policies and guidelines. * Develop a daily call schedule to ensure efficient and comprehensive coverage of territory which may include a certain number of calls per day/week. * Under close supervision of the RBM, complete administrative reports and meet related deadlines. Ensure proper safeguarding and care for company assets (laptop, iPad, fleet vehicle. etc.). * Maintain the stated expectations of number of calls per day defined as face-to-face interactions, with healthcare providers focusing on top target customers. * Enter calls immediately into Veeva System via iPad and check/respond to email daily.

Summary of Key Responsibilities: Develop and validate skin permeation and/or LC-MS/MS analytical test methods with minimal guidance from senior laboratory personnel Carry out laboratory work as directed by senior laboratory personnel Conduct routine analytical experiments using established analytical methods and procedures Assist with assembling and review of data packs Prepare detailed protocols and technical reports for development, validation, and post-validation activities Conduct experiments by developing new analytical methods or using established analytical methods including in vitro permeation testing techniques and LC-MS/MS Data entry into spreadsheets, as directed by senior laboratory personnel For LC-MS/MS experiments independently perform full data review of chromatography, transcription checking of spreadsheets, and calculation review of spreadsheets For Skin permeation/IVPT experiments transcription checking and calculation review of spreadsheets Review and maintain laboratory notebooks Assist in training of entry-level employees Manage essential laboratory activities including equipment maintenance schedules, chemical and laboratory supply inventory Required Qualifications and Skills: B.S with 3-8 years of experience, or M.S with 2-6 years of experience: focus in chemistry, biology, pharmaceutical sciences or related scientific discipline 2-5 years of experience in a GxP laboratory setting in the pharmaceutical industry Experience in either LC-MS/MS or IVPT/Skin permeation testing, troubleshooting and validation Demonstrated experience in developing and implementing new technologies, ways of working, and/or tools to improve capability Technical report writing proficiency Experience with other general laboratory instruments and wet chemistry techniques Proficiency in Analyst and/or MassLynx and MS Excel Speaks, writes, listens and presents information in a logical and articulate manner appropriate for the audience Thorough when performing work, conscientious about attending to detail, and uses logical thinking that is well-organized and methodical

The Validation Engineer will provide direct validation support to pharmaceutical development and manufacturing operations. This role performs validation activities accurately and completes documentation fully and compliantly.Key Responsibility Areas• Oversee Site Master Validation Program: Provide input and administration of the site master validation program as well as assist in maintaining the site validation master plan while following validation policies; maintain validation life cycle approach for site• Pharmaceutical Validation: Author/Execute process validation protocols and validation summary reports; perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification Specific ResponsibilitiesResponsibilities include, but are not limited to:Cleaning Validation• Collaborate with manufacturing to design and develop cleaning procedures and processes for cGMP equipment used in the manufacture of pharmaceutical product• Actively provide input and guidance in establishing cleaning process for new products and partner with new product development engineers for process development.• Collaborate with the cleaning verification and validation analytical group to develop and draft cleaning verification and validation protocols.• Review protocols, residue limits, reports and cleaning verification and validation summary packages.• Review new and/or updated Master Batch Records to evaluate impact on Cleaning Validation Program.• Provide technical expertise for pre-validation risk assessments using risk management tools to evaluate specific requirements for the cleaning process involving new compounds.• Advise on equipment improvements and/or replacements. Equipment/Utilities Qualification• Author/review URS and FRS documentation• Author/review equipment qualification protocols and summary reports• Author/review executed equipment qualification protocols and summary reports• Assist with the execution of equipment qualification protocols.• Production Oversight During Validation Events• Work to ensure validation documentation becomes part of the site's GMP documentation database• Work to create an environment of open communication, participation and information-sharing within and between teams within Quality Assurance and throughout facility Key Competencies/Requirements• Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others• Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems• Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services• Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates• Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas• Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people• Attentive to Detail: Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled• Interpersonal: Develop and maintain effective relationships with others; relate well to people from varied backgrounds and in different situations; show understanding, courtesy, tact, empathy, concern, and politeness Qualifications• Bachelor's degree in a Technical or Life Science• 5 - 7 years of validation experience in pharmaceutical manufacturing• Knowledgeable in cGMPs, ISO, SUPAC, and current FDA and industry standards.