Director, R&D Analytical Sciences
Tergus Pharma job in Durham, NC
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
Auto-ApplyInside Sales Representative
Tergus Pharma job in Durham, NC
We are seeking a highly self-motivated, competitive Inside Marketing and Sales representative to join our organization. This position will play a critical role in nurturing Leads, positioning the service lines, and establishing a positive brand impression.
Proactively prospect into targeted accounts, leveraging the R&D and CDMO Industry's best techniques and sales acceleration tools. The Sales Development Representative will generate meetings and promote Tergus Pharma's service line offerings to potential customers and engage with them as part of the Tergus Commercial Sales Team.
Working closely with the rest of the team, this individual will engage directly with customers and leads to qualify leads with opportunities and secure them for the sales organization. This individual will receive a base salary and discretionary annual bonus based on their performance.
Summary of Key Responsibilities:
· Perform required administrative functions, including database updates and email communications.
· Develop relationships with sales, marketing, and the event/conference community
· Prospecting of company and contact prior to contacting them to engage in a more personalized discussion/messaging. Know about their business and industry.
· Handle inbound and outbound calls to clients as directed to uncover opportunities to upsell new services
· Build working relationships with Business Development Managers and Sr. Business Development Executives to effectively build a prospect list.
· Coordinate activities related to events for the Business Development Managers, Sr. Business Development Executive and Executive Management.
· Call out to event attendees to confirm attendance and post event follow up.
· Able to identify new opportunities and pass to the Commercial Sales Team.
· Align with Business Development Manager and Sr. Business Development Executive to effectively create regional territory plans.
· Utilize and leverage internal technology to manage marketing leads/contacts effectively.
· Effective Data Management through internal and external sources, such as CRM, GlobalData/PharmSource, social media, and other tools.
Required Qualifications and Skills:
· Bachelor's degree, preferably in business administration, marketing, technical discipline, or an equivalent experience in the military is required.
· 3+ year of inside sales experience a plus
· Direct telephone and email selling experience
· Must be motivated and dependable with strong work ethics, metrics driven, a positive attitude, and an eagerness to learn.
· You must also be highly organized and detail-oriented with excellent communication skills and the ability to build business relationships.
· Customer focused, courteous, detail oriented, persuasive, and tactful
· Excellent communication skills both verbal and written
· Ability to multi-task while still maintaining attention to detail
· Experience in customer facing work
Auto-ApplyPackaging Technician I - 1st Shift
Wilmington, NC job
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.
Auto-ApplySample Login Administrative Support Specialist - Eurofins Built Environment Testing East - Cary, NC
Cary, NC job
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.
Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.
Job Description
This position is expected to assist and oversee all the different aspects of shipping, receiving, storing, distributing and logging samples.
Essential Duties and Responsibilities:
* Accepts and signs for deliveries.
* Uses dollies, forklifts, and other moving equipment to transport shipments from loading dock and around Sample Receiving area.
* Opens coolers and inspects contents of shipments. Checks documentation to ensure all samples are accounted for.
* Prepares samples for analysis.
* Enters records in LIMS system.
* Distributes samples in different departments as appropriate.
* Follows strict safety and quality control procedures.
* Stores, restocks, and shelves samples as necessary.
* Ensures that work area is clean and organized.
* Other duties as assigned.
Qualifications
Basic Minimum Qualifications (BMQ):
Education: High school diploma or GED is required.
Ability and/or Skills:
* Demonstrates strong organizational skills.
* Pays close attention to detail.
* Possesses physical strength necessary to lift and move heavy boxes
* received by the lab.
* Exhibits ability to use LIMS software competently.
* Possesses basic math skills.
* Works well with a team.
* Communicates clearly and effectively.
* Demonstrates strong interpersonal skills.
* Handles issues calmly and politely.
* Manages time efficiently.
* Demonstrates solid problem-solving skills.
* Is capable of operating forklifts and other equipment to move heavy
* shipments.
* Demonstrates awareness of safety procedures.
Additional Information
Requirements:
* Authorization to work in the United States indefinitely without restriction or sponsorship
* Professional working proficiency in English is a requirement, including the ability to read, write and speak in English
Position is full-time Monday - Friday 8:30 am - 5:00 pm. Candidates currently living within a commutable distance of Cary, NC are encouraged to apply.
Pay rate: $17/hr.
Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business sector, and geographic location.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. we offer excellent benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options.
* The benefits package offered will vary based on the employee's full-time or part-time regular status.
To learn more about Eurofins, please explore our website *******************
We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development.
We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.
Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!
Find out more in our career page: *****************************
Company description: 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 discovery pharmacology, forensics, advanced material sciences and Eurofins Scientific 2/2 March 2023 agroscience contract research 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 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 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 2022, Eurofins generated total revenues of EUR 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years.
Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.
Sample Coordinator - Group Leader
Holly Springs, NC job
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
Leadership Responsibilities:
Ensure adherence to highest quality and efficiency standards in laboratory operations.
Ensure cross training initiatives are in place and followed.
Foster morale and teamwork.
Ensure the reward and recognition programs are utilized to the fullest.
Ensure systems are implemented at the site to foster team morale.
Develop and maintain effective, trusting work and customer relationships.
Build loyal customer relationships.
Meet with Client's on a regular basis.
Lead team, schedule, and train employees in client-facing environment
Technical Responsibilities:
Interface with QC on sampling of Water, Gas and EMPQ
Peform LIMS labeling and materials rediness per shift
Organize sampling per shift
Liase with manufacturing by attending meetings, bring sampling activity to their attention
Work with manufacturing scheduler to insert sampling activities for equipment during production schedules
Coorindate with manfuacturing associates' samples to be done and track completion of sampling activity and results
Track sample analysis and/or deviations in LIMS to notify leads
Pull reports into report library
Qualifications
Completed Bachelors degree in a scientific concentration
Previous experience with Sample Management or Sample Coordinaton desired
Previous leadership experience is desired
Authorization to work in the United States indefiniately
Additional Information
This position is Full-Time, Mon-Fri 8am-5pm
with overtime as needed. Candidates currently living within a commutable distance of
Holly Springs, 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.
Quality Assurance Associate
Cary, NC job
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
Provides Administrative support by
* assisting with routine quality assurance activities
* performing administrative functions within the QA group
* supporting Quality-related Help Desk and e-mail requests
* assisting in Analytical Subcontractor documentation maintenance
Supports Data Reporting by:
* reviewing, approving, and releasing laboratory data
* assisting with review and approval of Certificates of Analysis and Cumulative Reports
* assisting with review and verification of Technical Reports and Summaries
Assists in Document Control by:
* issuing Master Lists numbers
* issuing Laboratory Notebooks and Logbooks
* issuing and maintaining Controlled Copies
* maintaining the Technical Library
* maintaining Archival of Records
Supports Stability activities as assigned
Supports Manufacturing activities as needed by:
* executing the quality assurance roles of batch records
* Other duties as assigned
Qualifications
Required: a minimum of High School Diploma or Equivalent. Preferred Bachelor's Degree and/or certifications in laboratory/quality/regulatory
Required: Understanding of FDA requirements and Quality Systems
Preferred: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)
Preferred: 1 - 2 Years in a laboratory environment.
Preferred: 3+ years of GLP/GMP environment in laboratory operations or QA, or combination of both
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.
Metrologist
Morrisville, NC job
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.
Auto-ApplyConsultant Pediatrician
Winston-Salem, NC job
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.
Scientist II - QC Chemistry
Wilmington, NC job
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 II (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 II (Chemistry) position, HPLC, TOC, UV, osmolality, density, and pH are commonly employed in the described testing in addition to other key methodologies such as KF and titration. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by The Company) and may also assist with method development / method validation projects.
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.
Performs GMP review of solutions and wet chemical analyses.
Performs technical review of typical laboratory data and HPLC analysis.
Writes test procedures, protocols, and reports.
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
Masters degree in Chemistry, Biochemistry, or related field with 0+ years of related work experience.
Bachelor's degree in Chemistry, Biochemistry, or a related field with course work in Chemistry with 4+ years related work experience.
Or Associates degrees in Chemistry or related field with 10+ years related experience.
Knowledge, Skills, and Abilities
Excellent verbal and written communication and documentation skills required.
Strong detail orientation and organizational skills required.
Strong problem-solving and basic trouble-shooting ability required.
Strong knowledge of Laboratory equipment and safety required.
Strong knowledge of Laboratory Documentation is required.
Strong 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.
Auto-ApplyDirector, Manufacturing Quality Operations
Morrisville, NC job
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, Manufacturing Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Director, Quality provides leadership to the site Quality team who performs quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives; directs the implementation of quality plans and works with lab management to ensure department goals and objectives are met. The Director of Manufacturing Quality Operations interacts with clients and regulatory agencies regarding quality issues, audits, and inspections.
On-Site Expectations
100% on-site position.
1st Shift: Monday - Friday, 8:00am - 5:00pm.
Responsibilities
Ensures GMP compliance with regulatory requirements and Company procedures. Specifically, 21 CFR parts 4, 210 and 211.
Collaborates with corporate quality functions to ensure site compliance with the company's Quality Management Systems (QMS).
Collaborates with site Operations and Technical leadership to ensure timely closure of deviations, non-conformance investigations, corrective actions, and other Quality documents.
Conducts thorough root-cause analysis for investigations.
Implements corrective and preventive actions to eliminate repeat observations.
Guides, instructs, and coaches members of management in quality and compliance issues.
Provides direct support and leadership during site regulatory inspections to ensure minimal observations.
Engages in client audits and client interactions.
Assists in driving on-time site responses to regulatory and client audit reports and provides direct oversight on commitments and content.
Develops and implements systems to aid in efficiency and compliance improvements for the site.
Develops short and long-range goals and objectives for the site quality function.
Develops, implements and maintains internal auditing program.
Ensures controlled documentation is generated, revised, approved and maintained per corporate and regulatory agency procedures.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Attracts, develops, and retains 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.
Other duties as assigned.
Qualifications
Bachelor's degree (Chemistry, Biology, Microbiology, Engineering) required.
10+ years of pharmaceutical quality experience required, 12+ years preferred related experience in other pharmaceutical disciplines will be considered; 6+ years of management experience required.
Prior pharmaceutical experience in sterile manufacturing, including syringe manufacturing, is required; prior CDMO experience preferred.
Prior experience with final product release, major equipment validation, validation protocol review, process validation protocol review, 21 CFR Part 4/ISO 13485 and APRs preferred.
Knowledge, Skills, and Abilities
Expert knowledge of pharmaceutical regulatory requirements and cGMP required.
Knowledge of quality systems and processes, change control, CAPA and data integrity required.
Knowledge of aseptic processing of commercial or clinical parenteral required for parenteral site(s).
Knowledge of auditing preferred.
Excellent skills in leadership, coaching and influencing others, strategic planning, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.
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 correspondences.
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.
Auto-ApplyLaboratory Technologist
Winston-Salem, NC job
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 Donor & Product Testing is looking for a clinical laboratory technologist to assist with providing comprehensive laboratory services to meet the unique testing needs of the transplant community. Our clinical labs preform microbiology testing to determine microbial cleanliness, infectious disease and donor eligibility testing, as well Human Leukocyte Antigen (HLA) testing to successfully match organ transplant recipients with compatible donors. If you are looking for a fun exciting opportunity with the ability to make a positive impact in the lives of donors and transplant recipients look no further!
Technologist I responsibilities include, but are not limited to, the following:
* Following prescribed procedures, performing any of the tests within any of the laboratory specialties. Calculating the results of the tests performed in necessary
* Operating, calibrating, conducting performance checks, and maintaining any laboratory analyzers or equipment
* Recognizing and correcting basic analyzer malfunctions and notifying management personnel when appropriate
* Preparing reagents or media from a prescribed procedure
* Evaluating media, reagents, and calibrators according to established criteria
* Conducting established quality control procedures on analytical tests, equipment, reagents, media, and products
* Evaluating results of quality control and implements corrective action when indicated
* Determining performance specifications for new methods
* Confirming and verifying results through knowledge of techniques, principles, and analyzers
* Monitoring quality assurance/continuous improvement programs
* Monitoring safety programs in compliance with laboratory regulations
* Utilizes laboratory information systems or other methods to accurately and effectively report patient results
* Writing laboratory procedures conforming to standardized format
* Reporting test results conforming to established procedures
Qualifications
* Bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution
* Authorization to work in the United States indefinitely without restriction or sponsorship
The ideal candidate would possess:
* Knowledge of the principles, methods, materials, equipment, and techniques of medical technology
* Knowledge of the principles of chemistry, biology, and bacteriology as related to medical technology
* Some knowledge of recent developments in the field of medical technology
* Ability to instruct subordinate technologist in areas of medical laboratory testing
* Ability to perform assigned tasks according to prescribed procedures and to make accurate observations and records of tests results
* Skill in the use of medical laboratory equipment
* Analytical thinking and communication skills
* 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
Additional Information
Pay Range:
* $20.00-$24.00 per hour
Schedule:
* Wednesday-Saturday 10:00pm-8:30am
What we offer:
* 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 Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.
Sr. Supervisor, Metrology - GMP
Wilmington, NC job
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.
Auto-ApplySAP ABAP Developer
Durham, NC job
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.
Auto-ApplyMicrobiologist
Winston-Salem, NC job
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
Essential Duties and Responsibilities:
* 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
* Perform routine and non-routine serial dilutions and plating using excellent sterile technique
* Perform an enumeration of plated samples with a high degree of accuracy
* Measure water activity, conduct moisture analyses on tobacco samples according to prescribed methods.
* Operate, maintain, and troubleshoot laboratory equipment
* Perform instrument calibration and daily equipment checks
* Participate in laboratory exceptions and the CAPA process
* Read, understand, and follow methods and procedures as assigned
* Record and review data accurately
* Perform validation of media, reagents, and methods
* Review, write, or revise SOP's, reports, protocols
* Maintain ability to adjust working hours or work overtime and weekends, based on client needs.
* Excellent communication skills (oral and written)
* Communicates effectively with client staff members
* Conducts all activities in a safe and efficient manner
* Performs other duties as assigned
Qualifications
* B.S Degree in microbiology, biology or equivalent
* Experience using aseptic techniques.
* Experience performing serial dilutions and plating
Additional Information
* Position is full-time, Monday-Friday, 8:00 am - 5:00 pm.
* 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.
Senior Supply Chain Specialist / Buyer - GMP
Morrisville, NC job
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 Senior Supply Chain Specialist / Buyer is responsible for ensuring timely and compliant procurement, effective inventory control, and seamless material availability to support manufacturing operations across Alcami's sites. This cross-functional leadership role supports the end-to-end supply chain-from strategic sourcing and supplier management to material flow and system execution-bridging Supply Chain, Procurement, Manufacturing, and Quality. The role requires strong expertise in SAP (MM/IM/WM), GMP environments, and direct materials purchasing, with a proven ability to manage multi-site operations and lead continuous improvement initiatives.
On-Site Expectations
100% on-site position.
1st Shift: Monday - Friday, 8:30am - 5:30pm.
Responsibilities
Lead sourcing strategies and negotiate supplier agreements for direct materials across multiple Alcami sites.
Place and manage purchase orders to align with production forecasts and schedules, ensuring on-time material availability.
Manage supplier relationships, including qualification, performance monitoring, issue resolution, and compliance with Quality and Regulatory expectations.
Ensure adherence to contract terms, service levels, and documentation requirements, including supplier specifications and compendia updates.
Monitor inventory levels and material flow across sites to support production needs, mitigate risk, and maintain supply continuity.
Coordinate material movements, including receiving, staging, transfers, and disposal of expired materials in alignment with SOPs.
Prepare and present inventory reports based on business and customer needs.
Leverage SAP (MM/IM/WM) to manage procurement and inventory transactions, including vendor and material master data, PO lifecycle, and batch management.
Act as a subject matter expert for materials management in SAP, driving data integrity and process consistency across sites.
Analyze material usage and supply data to identify bottlenecks and implement improvement initiatives.
Collaborate with Planning, Manufacturing, Quality, and Finance to execute Plan-to-Manufacture (P2M) and Procure-to-Order (P2O) processes.
Support internal and client communications regarding material availability and supply issues, offering alternative solutions as needed.
Ensure compliance with GMP, GDP, and internal procurement and quality standards.
Provide mentorship to junior team members and cross-functional support as needed (e.g., shipping, receiving, material handling).
Promote audit readiness and represent the supply chain function in regulatory inspections.
Support continuous improvement by analyzing consumption trends, identifying bottlenecks, and implementing corrective actions.
Other duties as assigned.
Qualifications
Bachelor's degree in Supply Chain, Operations Management, Engineering, or related field (required); APICS/CPIM certification a plus.
7+ years of materials or inventory management experience within a pharmaceutical, biotech, or CDMO environment.
Previous work experience in a CDMO manufacturing environment preferred.
Prior pharmaceutical/industry GMP experience required.
Knowledge, Skills, and Abilities
Demonstrated proficiency in SAP Inventory Management (IM), Warehouse Management (WM), Plan-to-Manufacture (P2M), and Procure-to-Order (P2O) processes.
Deep proficiency in SAP MM (P2P) with working knowledge of vendor master, source lists, and PO processing.
Strong negotiation skills and ability to manage supplier relationships across domestic and international markets.
Demonstrated ability to drive cost savings while ensuring supply reliability and compliance.
Experience supporting material staging, production order kitting, and goods issue to process orders.
Proven track record managing inventory across multiple manufacturing and distribution sites.
Proficiency with MS Office Suite especially Word, Excel, and Outlook.
Ability to perform assigned tasks carefully and on schedule according to standard operating procedures and supervisor's instructions.
Ability to work with people at all levels of the organization.
Excellent verbal communication skills required.
Travel Expectations
Up to 20% travel required excluding training which will require travel.
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.
The noise level in the work environment is usually quiet with periods of higher noise elevations when present in warehouse or manufacturing areas. The employee may be required to gain access to manufacturing personnel via general manufacturing areas only for work discussions or follow-up or be required to tour clients through the various facilities. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.
#IND1
Auto-ApplyAutomation Engineer/Controls Engineer
Morrisville, NC job
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 Automation Engineer is accountable for driving results in a fast-paced environment by being responsible for multiple capital and process improvement related projects. The Automation Engineer's primary responsibilities will center around:
Evaluating and implementing new ways to automate systems that drives efficiency and compliance.
Testing automation equipment and processes (driving FAT, SAT, and commissioning activities within the Engineering Department and aiding the Validation Department with qualification efforts).
Programming new automated components (i.e. door interlock systems, etc.).
Evaluating existing auto-generated reports for improvement and provide requirements for future auto-generated reports.
Maintain current automation systems to ensure all software is current and running on the appropriate platform.
On-Site Expectations
100% on-site position.
1st Shift: Monday - Friday, 8:00am - 5:00pm.
Responsibilities
Designs and/or implements manufacturing technology to automate production processes and equipment and supports production operations from an equipment and process troubleshooting standpoint as well as implement production efficiency improvements. Automation Engineers are expected to hold both a project management and production support workload.
Project Management: Engineering responsibilities include developing user and design requirements, selecting equipment vendors or completing the technology design and equipment build in-house, managing the installation of automation while ensuring safety, and supporting the validation of the automated system for adherence to requirements, CGMPs, and intended system operation.
Production Support: Support Maintenance Technicians in situations where troubleshooting or technology may fall outside of their area of expertise. Interact with production supervisors/managers to identify areas to improve equipment throughput, flexibility, quality, safety, and/or reliability. Implement automation solutions resulting from deviations, investigations and/or CAPA assignments.
Composes Functional Requirement Specifications (FRSs) for new or upgraded utilities systems, compounding processes, and filling equipment.
Designs and/or implements modifications to the existing manufacturing equipment that will improve the operational efficiencies.
Acts as engineering and technical lead for key plant projects.
Provides technical support for and leads safety and quality improvement initiatives.
Programs PLCs, HMIs, SCADA systems, and inspection systems.
Manages multiple capital projects concurrently.
Designs, installs, and supports the validation of the automated control system for new or upgraded utilities systems, compounding processes, and filling equipment.
Generates and revises standard operating procedures.
Leads Manufacturing Deviation investigations and applies good engineering practices to reduce the risk of repeat Non-Conformances.
Implements corrective and preventative actions to improve manufacturing's operational efficiencies.
Performs risk assessment and risk mitigation activities using systematic tools.
Participates in internal discussions with internal customers to determine timing for project execution and sequencing of various project milestones.
Requests bids from contractors and suppliers by working with procurement group, recommends best provider.
Formalizes CAPEX document preparation and submission.
Maintains company reputation by complying with applicable federal and state regulations. Demonstrates company loyalty in relations with company personnel.
Maintains a safe, clean, and organized work environment free of safety hazards.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.
Qualifications
Bachelor's degree in engineering or related field required.
Minimum 4 years' experience in Automation / Controls Engineering.
Previous work experience in a sterile manufacturing environment preferred.
Experience with robotics, AI, and machine learning.
Experience with project management.
Knowledge, Skills, and Abilities
Mastery of a variety of automation software applications. Software applications include but are not limited to the Allen-Bradley RSLogix portfolio, Allen-Bradley RSView, GE Proficy SCADA/HMI iFix. The following are highly desired:
Exemplary knowledge of discrete machine control; AB Safety PLCs, Gearboxes, Safety Circuits, Pneumatics, etc.
Mastery of Data Historian
Ability to perform assigned tasks carefully and on schedule according to standard operating procedures and supervisor's instructions.
Ability to work with people at all levels of the organization.
Ability to perform complex math functions, compute ratios, rates, and percentages.
Ability to draw and interpret graphs and charts.
Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
Excellent verbal communication and presentation skills required.
Proficiency with Microsoft Office applications.
Proficiency in maintaining automation equipment.
Solid understanding of computer programming and software development.
Ability to troubleshoot equipment and perform complex system tests.
Strong leadership and problem-solving skills.
Strong analytical skills.
Ability to keep up with the latest technologies.
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. The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.
Auto-ApplyAccounts Receivable Assistant - Eurofins Environment Testing, Burlington, WA
Burlington, NC job
Eurofins Scientific is a network of independent companies 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 to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.
Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.
With over 50 laboratories and more than 40 service centers nationwide, Eurofins Environment Testing provides full-service environmental analysis across all 50 states. Our network supports public and private clients-including DoD, DOE, and municipalities-through robust logistics and continuous investment in people, technology, and infrastructure. We offer comprehensive testing for air, water, soil, sediment, tissue, and waste, covering a wide range of analytes including PFAS, metals, VOCs/SVOCs, dioxins/furans, radiochemicals, and more.
Job Description
Eurofins Environment Testing Northwest is seeking a full-time Accounts Receivable Assistant to join our team!
The Accounts Receivable Assistant will assist the Accounts Receivable Lead in interacting with internal and external clients on a daily basis, submitting invoices to electronic invoice portals, monitoring assigned client accounts and performing collection tasks as needed, analyzing and processing requests in a timely manner with little or no supervision; solving problems and answering questions; assessing situations and initiating a course of action.
Essential Duties and Responsibilities:
* Applies GMP/GLP in all areas of responsibility, as appropriate
* Demonstrates and promotes the company vision
* Regular attendance and punctuality
* Research and respond to client requests (internal/external) in a clear, concise, and professional manner
* Serve as main invoicing contact for all clients using electronic invoicing portals.
* Monitor an assigned list of client accounts and perform collection tasks as required
* Work with project management to review and implement client requirements for electronic invoicing
* Upload invoices to client billing systems as needed
* Address invoicing issues directly with client and follow-up with client until issue is resolved
* Work on special projects as requested
* Attends meetings as requested
* Conducts all activities in a safe and efficient manner
* Performs other duties as assigned
Qualifications
* Associate Degree in business or related discipline or two years experience in accounts receivables or customer service
* Basic computer skills including typing
* Ability to communicate verbally and in writing
* Bachelors degree in related field, preferred
* Previous experience with accounts receivables and customer service
* Experience with credit cards and collections
* Excel knowledge and general math skills
* Ability to work independently and with a group
* Problem-solving skills
* Authorization to work in the United States indefinitely without restriction or sponsorship.
* Professional working proficiency in English is required, including the ability to read, write, and speak in English.
Additional Information
This is a Full-time position, Monday to Friday from 8 am to 5 pm with possibility of overtime.
Compensation: $21-24 / hour (DOE)
Candidates within a commutable distance of Burlinton, WA are encouraged to apply.
Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base salary may vary based upon, but not limited to, relevant experience and skill set, base salary of internal peers, business sector, and geographic location.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays, paid time off, and dental and vision options.
To learn more about Eurofins, please explore our website ******************
We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development.
We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.
Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!
Find out more in our career page: *****************************
Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.
Scientist II IVPT
Tergus Pharma job in Durham, NC
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
Auto-ApplyValidation Engineer
Tergus Pharma job in Durham, NC
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.
Auto-ApplyEngineering and Maintenance Director
Tergus Pharma job in Durham, NC
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.
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