Pharmaceutical Sciences Jobs in Usa

Vanda Pharmaceuticals (NASDAQ: VNDA) is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients. We are looking for a Neuroscience Account Manager who wants to join an innovative and dynamic sales organization. We are seeking top talent to join our high-performance sales team to make a difference in patients' lives every day and be part of building a great company. The primary responsibility of the Neuroscience Account Manager, which reports to the Neuroscience District Sales Manager, is to exceed the established goals by delivering real value to our customers through differentiated products and services.

Primary Responsibilities:

• Execute and promote products in alignment to sales strategy in the assigned territory.
• Frequent collaboration with the District Sales Manager to respond to their day-to-day sales and strategy direction related to product promotion activities.
• Analyze local market, develop, execute, and monitor performance and results to maximize the appropriate use of the product in defined territory.
• Maintain a high and current level of product, disease, competitive and market reimbursement knowledge.
• Determine, implement, and monitor optimal resource (i.e., budgets, time, etc.) allocation within assigned territory.
• Effectively and persuasively communicate using advanced selling and negotiation skills, relevant information to identified target audiences.
• Identify, build, and leverage advocacy channels.
• Secure product access and reimbursement within institutional systems as needed.
• Manage travel and promotional budget.
• Fulfill all monitoring and reporting requirements including expenses and call reporting using approved systems and processes.
• Maintain full compliance with all laws, regulations, and Vanda Policies.
• Continued employment requires meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers, customer facilities, and state/local governments.
• Additional, ad-hoc projects, as needed.

Education & Experience Requirements:

• BS or BA with GPA greater than 3.0.
• Minimum 3 years of pharmaceutical sales experience preferred.
• Candidates not meeting the work experience requirements may be considered for the \"Associate\" role.
• Atypical anti-psychotic experience and/or orphan drug experience preferred.
• Preferred specialty experience in psychiatry, bipolar, depression, CNS or pain management will be considered.
• Reimbursement experience preferred.
• Existing relationships (or those within 24 months) with psychiatrists and/or Community Mental Health Centers in the assigned territory is preferred.
• Valid driver's license and a clean driving history.
• Self-Starter, Goal and Results driven proven track record of above average results.
• Possess fortitude to sell and compete and driven with 'hunter' mentality.
• Strong relationships and knowledge of the territory preferred.
• Ability to travel (may include overnights).
• Out-of-territory travel to HQs, training, and sales meetings may be required.
• Work hours may include meetings scheduled outside of normal working hours.
• Must reside within territory geography.

Performance Competencies:

• Goal and results driven proven record of above average results.
• Highly clinical, patient centric and tactical with excellent communication skills (interpersonal, verbal, written).
• Ability to navigate complex markets and organizations.
• Outstanding work ethic and organizational skills.
• Dynamic, high-impact individual with effective selling and presentation skills.
• Ability to manage multiple priorities independently and make sound decisions.
• Ability to read situations quickly and adjust for roadblocks.
• Customer-focused, self-motivated, and computer proficient.
• Must possess and maintain a valid driver's license and an acceptable driving record, and be able to operate a motor vehicle as required for local, regional, and occasional overnight travel.
• May occasionally require lifting and/or moving items up to 15 pounds.

Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship.

The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, a car allowance, and other benefits to its employees.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.

Careers With Purpose Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States.

We're proud to offer many development and advancement opportunities to our nearly 50,000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint.

Facility: Bemidji Medical Center Location: Bemidji, MN Address: 1300 Anne St NW, Bemidji, MN 56601, USA Shift: 10 Hours
- Night Shifts Job Schedule: Full time Weekly Hours: 35.00 Salary Range: $58.00
- $87.50 Pay Info: Eligible for new hire sign-on bonus! Department Details
- 7 days on 7 days off
- rotating shifts
- Shift: 8:30pm
- 7:00am Job Summary Review prescriptions to assure accuracy, to ascertain the needed ingredients, and to evaluate their suitability.

Provide information and advice regarding drug interactions, side effects, dosage, and proper medication storage.

Counsels patients on the medication prescription including but not limited to: proper administration, possible side effects, expected response, storage and any other questions posed by the patient.

Monitors the health and progress of patients in response to drug therapy.

Must be able to learn and utilize new technology as the profession of pharmacy evolves.

Provides oversight and clinical supervision for pharmacy series and pharmacy support personnel.

In a medical center or institutional setting, the Pharmacist reviews and interprets provider orders, provides drug information, assists in problem solving, and provides other aspects of pharmaceutical care.

Duties may consist of unit dose dispensing, IV Admixtures, outpatient prescriptions, navigating the electronic medical record, compounding, and working with automated dispensing devices.

The Pharmacist utilizes appropriate age-related patient information to assess the pharmaceutical needs of patients, which may include provision of pharmaceutical care to neonatal, pediatric, adolescent, adult, and geriatric patients.

The Pharmacist follows all established regulations and standards that govern the practice of pharmacy.

May be required to act as a shift supervisor under direct or indirect supervision by department managers.

Demonstrates good written and verbal communication skills.

Must be able to learn and utilize new technology as the profession of pharmacy evolves.

Provides oversight and clinical supervision for pharmacy services and pharmacy support personnel.

Pharmacy services at Sanford Health may include involvement in acute care surgery, neurology, cardiology, pediatrics, oncology, infusion services, intensive care, general medicine, dialysis, transplant, antimicrobial stewardship, and medication reconciliation.

May include decentralized clinical functions, such as direct patient interaction/interdisciplinary team rounding, chart reviews, customer or patient counseling, collecting accurate medication list.

May also include centralized clinical functions, such as checking and dispensing medications and overseeing the clinical functions of the IV room.

Qualifications In a retail/community pharmacy setting: Graduate of an accredited School of Pharmacy.

Must have a thorough knowledge of drugs and their actions; knowledge of state and local regulations.

In a medical center or institutional setting: Graduate of an accredited School of Pharmacy.

Must have a thorough knowledge of drugs and their actions; knowledge of state and local regulations.

Hospital experience or residency preferred.

License must be in good standing by the State Board of Pharmacy in state(s) of practice and/or possess multi-state licensure privileges as required by position.

Benefits Sanford Health offers an attractive benefits package for qualifying full-time and part-time employees.

Depending on eligibility, a variety of benefits include health insurance, dental insurance, vision insurance, life insurance, a 401(k) retirement plan, work/life balance benefits, and a generous time off package to maintain a healthy home-work balance.

For more information about Total Rewards, visit .

Sanford is an EEO/AA Employer M/F/Disability/Vet.

If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1-877-673-0854 or send an email to .

Sanford Health has a Drug Free Workplace Policy.

An accepted offer will require a drug screen and pre-employment background screening as a condition of employment.

Req Number: R-0248205 Job Function: Allied Health Featured: No d24ad0b8-823f-4e68-a892-2986ccdf7392

Careers With Purpose Sanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States.

We're proud to offer many development and advancement opportunities to our nearly 50,000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint.

Facility: Bemidji 1611 Clinic Location: Bemidji, MN Address: 1611 Anne St NW, Bemidji, MN 56601, USA Shift: 8 Hours
- Day Shifts Job Schedule: Full time Weekly Hours: 40.00 Salary Range: $58.00
- $87.50 Pay Info: Eligible for new hire sign-on bonus! Department Details Join a great team providing outpatient anticoagulation services to the Bemidji region.

This is a Monday through Friday position with no holidays or weekends.

The pharmacist will primarily be responsible for staffing the anticoagulation clinic and will work closely with a team of five nurses and an ambulatory care pharmacist.

As our ambulatory care program continues to expand, this role will have opportunities to provide additional ambulatory care pharmacist services.

Job Summary Responsible for providing pharmaceutical care services for the outpatient Anticoagulation Clinic (AC).

Works collaboratively with pharmacy staff, nursing staff, medical staff, and other pertinent healthcare providers to assess medication use systems, identify opportunities to improve anticoagulation use safety, and institute practice changes, as necessary.

Consistently demonstrates leadership and assumes ownership for the implementation of an efficient and effective outpatient AC.

Provide management of AC patients by providing follow up monitoring and necessary interventions to ensure enhanced safety and effective outcomes associated with the outpatient AC.

Provides pharmaceutical care by following established standards and practices consistent with Sanford policy, regulating bodies (TJC, CMS, etc.) and professional practice standards as well as state and federal law.

Work closely in collaboration with the AC nurses to deliver safe and effective care.

Visible and readily accessible to the clinical staff in the various medical staff and other clinical departments.

Must understand the role of systematic practices in leading to safe and effective patient care and have the ability to implement these practices in multiple settings.

Possesses the ability to cooperate at all levels, both inside and outside of the AC.

Demonstrates the ability to understand and verbalize the dissemination of drug information, to develop procedures and plans and to supervise students and residents.

Demonstrates excellent written and verbal communication skills.

Has knowledge of and utilizes appropriate age-related patient information relating to the pharmaceutical needs of neonatal, pediatric, adolescent, adult and geriatric patients.

Qualifications Must be a graduate from an accredited School of Pharmacy.

Doctor of Pharmacy or Master's Degree in comparable area is required.

Successful completion of an American Society of Hospital Pharmacists (ASHP) accredited residency is desirable.

Minimum one year of clinical practice experience.

Prior experience in an anticoagulation service is desirable.

Must have current state licensure to practice pharmacy.

Must obtain a license to practice pharmacy in other states, if applicable, within three months of employment.

Board of Pharmacy Specialties Board Certification in Pharmacotherapy, Ambulatory Care, or Cardiology, or obtaining recognition as a Certified Anticoagulation Care Provider is required within two years of employment in this position.

Benefits Sanford Health offers an attractive benefits package for qualifying full-time and part-time employees.

Depending on eligibility, a variety of benefits include health insurance, dental insurance, vision insurance, life insurance, a 401(k) retirement plan, work/life balance benefits, and a generous time off package to maintain a healthy home-work balance.

For more information about Total Rewards, visit .

Sanford is an EEO/AA Employer M/F/Disability/Vet.

If you are an individual with a disability and would like to request an accommodation for help with your online application, please call 1-877-673-0854 or send an email to .

Sanford Health has a Drug Free Workplace Policy.

An accepted offer will require a drug screen and pre-employment background screening as a condition of employment.

Req Number: R-0244966 Job Function: Allied Health Featured: No d24ad0b8-823f-4e68-a892-2986ccdf7392

About Fennec

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of PEDMARK® to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, PEDMARK® received FDA approval in September 2022 and European Commission approval in June 2023 and U.K. approval in October 2023 under the brand name PEDMARQSI®. PEDMARK has received Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe which includes eight years plus two years of data and market protection.

At Fennec we are focused on the mission to serve patients and take pride in our hustle, determination, and collaboration with all stakeholders. We are growing and excited to have opportunities for our employees to experience making an impact on the lives of the patients we serve as well as creating opportunities for themselves and their careers. 

About the Role

Within the assigned territory the position is responsible for driving new business, achieving profitable territory results, developing and maintaining relationships with our provider customers of PEDMARK in Nebraska, Iowa, and Missouri. Educating HCPs through strong professional relationships built with trust and reliability are the cornerstone of a successful Territory Manager. Each Territory Manager will build, manage, and execute business plans that will deliver on company sales objectives. All employees are expected to demonstrate integrity, and compliance with all interactions and adhere to industry guidelines. 

Responsibility

• Achieve/Exceed PEDMARK sales goals by maximizing revenue and market share in the assigned territory. Masters in-depth knowledge of the product, market, customers and distribution model.
• Educates and promotes PEDMARK to cisplatin prescribing Oncologists, NPs, PAs in pediatric, academic and community sites of care. 
• Uses in-depth product knowledge that includes the safety and efficacy of PEDMARK to make compelling, compliant, and persuasive sales calls to customers resulting in PEDMARK sales.
• Must be a skilled collaborator who can build significant internal and external stakeholder relationships to deliver on the PEDMARK promise. 
• Heart of a champion. Must have a passion to serve others, operate every day with a sense of urgency, and manage multiple accounts.
• Sells PEDMARK adhering to company’s business ethics, compliance policy, marketing message, and company strategy.
• Work together with company’s medical and patient services teams to build and maintain high quality customer relationships. Must be skilled at scheduling, coordinating, and following through with planned programs including medical education, provider in-services, and executive exchanges.
• Continuously improves selling skills and product knowledge through self-driven behaviors as well as the successful completion in company training programs.
• Responsibly manages and utilizes company resources, including territory budget, company literature, and marketing materials.
• Operate within full compliance of OIG guidelines as directed by Fennec Pharmaceuticals
• Accurately report sales activities through the consistent use of company directed and provided tools
• Create and submit timely and accurate expense reports using assigned expense system

Qualifications

• BA/BS degree required
• 2 – 5 + years of successful B2B selling experience required
• Documented consistent rankings in the top 20%
• Strong interpersonal skills, excellent communication, facilitation and presentation skills
• Ability to network and develop strong professional relationships
• Skilled at prioritization and demonstrating initiative, working independently to address issues and solve problems.
• Self-motivated to build PEDMARK customer advocates through relationships.
• Unwavering patient-first mindset
• Exceptionally skilled at organizing and effectively managing time in territory
• Flexible and adaptable in dealing with change in a growing work environment
• Overnight travel varies depending on territory size

Compensation & Benefit Summary

We understand compensation is an important factor as you consider the next step in your

career. Below is an overview of the compensation and benefit its offerings.

Base salary range: $95,000-$120,000

The estimated salary range reflects an anticipated range for this position. The actual base

salary offered may depend on a variety of factors, including the qualifications of the

individual applicant for the position, years of relevant experience, specific and unique

skills, level of education attained, certifications or other professional licenses held.

Employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan,

short-term and long-term disability coverage, basic life insurance, company holidays,

vacation, cell phone and WiFi reimbursement, a bonus, and stock options.

A&Z Pharmaceutical has been a trusted leader in developing, manufacturing, and marketing high-quality pharmaceutical products and nutritional supplements for over 30 years. Our product portfolio caters to all stages of life, from newborns to seniors, offering immense nutritional value and promoting well-being. Known for flagship brands like D-Cal® and MFIT Supps®, A&Z also operates a global pharmaceutical division, AiPing®, specializing in Contract Development and Manufacturing. With over 450 employees, dedicated research laboratories, and advanced manufacturing facilities, we embody our mission to "Advance Healthier Lives®" through quality, education, and innovation.

A&Z is seeking a full-time, on-site Purchasing Manager to join our team in Hauppauge, NY. The Purchasing Manager/Sr. Manager is responsible for the day-to-day requirements of purchasing goods and services for the company in an efficient and economical manner following established policies and procedures.

Job Responsibilities

• Issue purchase orders and tracking material and information requests.
• Source materials for new projects as requested, identify alternate sources for the new products based on price reduction strategies, any potential compliance issues, leading supplier evaluations, and leveraging market intelligence
• Manage all requests from various departments for their current and future project
• Procurement of API, excipients, and search for possible suppliers for their new projects
• Build and maintain strong relationships with vendors, negotiating favorable terms and managing performance.
• Develop and enforce procurement policies, optimize processes, and utilize technology for efficiency.
• Manage departmental budgets, analyze costs, and drive total cost reductions.
• Coordinate timely delivery and manage inventory levels
• Enter purchase requisitions, purchase orders and generate receivers in JDE
• Create electronic copies of PO/Receiver in the system central folders
• Ensure that PO acknowledgements details are correct and update promise dates
• Follow up PO delivery dates, order discrepancies or quality issues
• Attach pertinent documents to POs in JDE including quotes, proofs, specs
• Update reports, savings/increase, part/vendor master files.
• Sample requests and tracking to support new product development
• Report and track competitive bids.

Education, Experience & Skills

• Bachelor’s degree and 2+ years purchasing/industry experience - required
• Proficient in Microsoft Office Suite.
• Knowledge of JDE software a plus
• Organized and self-motivated. Ability to multi-task.
• Strong negotiation, analytical, financial acumen, leadership, communication, and risk management skills.
• Market trends, industry best practices, relevant laws, and procurement software.

Salary will be determined with experience.

Do you want to work at one of the top 100 hospitals in the nation?

ChristianaCare is currently recruiting for a Clinical Staff Pharmacist to join our team.

Life is full of choices, and ChristianaCare recognizes whom you work for is an important decision. Choose an organization that values pharmacy services and provides the opportunity to impact the health of our community adhering to our Core Values and Behaviors guided by Excellence and Love.

This position is full-time (80 hours bi-weekly) day/evening shift rotation. Every fourth weekend required and holidays as required.

Why ChristianaCare?

• At the Newark Campus, operations run through a network of pharmacists, including a central pharmacy and satellite pharmacies that focus on critical care, emergency medicine, heart failure, investigational drugs, neonates, oncology, pediatrics, perioperative services, sterile and non-sterile compounding, transplant, and trauma.
• Clinical services include robust acute and ambulatory care services. In the acute care setting, the department employs a decentralized model of practice, placing pharmacists directly into patient care units as part of a multidisciplinary team. 
• Generous PTO and 12-Week Fully Paid Parental Leave
• 403(b) with competitive employer match and Defined Contribution Retirement Plan
• Not-for-profit organization eligible with the Public Service Loan Forgiveness (PSLF) program
• Pharmacy Board Certification reimbursement

As an Inpatient Pharmacist you will:

• Review and interpret provider orders and dispense medication
• Evaluate drug efficacy and review for contraindications/precautions

• Clarify and resolve questioned orders with providers prior to dispensing initial doses.
• Manage specific medication therapies per approved policies (e.g., warfarin, aminoglycosides, vancomycin, IV to PO conversions, renal dose adjustments, indication-directed dose adjustments, selection of surgical prophylaxis medications)
• Provide drug information to allied healthcare professionals.
• Coordinate and supervise work-place activities
• Assume responsibility of the satellite pharmacies including the sterile product processing in the IV Admixture Service lab and OR pharmacy

EDUCATION AND EXPERIENCE REQUIREMENTS:

• Bachelor of Science degree in Pharmacy or PharmD degree from an accredited College of Pharmacy required
• Hospital pharmacy experience preferred but not required
• Current licensure (or eligible to reciprocate) in the State of Delaware

About ChristianaCare:

ChristianaCare is one of the country's most dynamic health systems, centered on improving health outcomes, making high-quality care more accessible and lowering health care costs. ChristianaCare includes an extensive network of outpatient services, home health care, hospital care at home, medical aid units, three hospitals (1,300 beds). We provide a Level I trauma center, Level III neonatal intensive care unit, a comprehensive stroke center and regional centers of excellence in heart and vascular care, cancer care and women's health. We rank 21st in the nation for hospital admissions and 6th for admission of stroke patients. ChristianaCare is a not-for-profit teaching health system with our outstanding, data-powered care coordination service and a focus on population health and value-based care. ChristianaCare is shaping the future of health care!

If you 're inspired to make a difference, we invite you to become a ChristianaCare caregiver.

Christiana Care Health System is an equal opportunity employer, firmly committed to prohibiting discrimination, whose staff is reflective of its community, and considers qualified applicants for open positions without regard to race, color, sex, religion, national origin, sexual orientation, genetic information, gender identity or expression, age, veteran status, disability, pregnancy, citizenship status, or any other characteristic protected under applicable federal, state, or local law.

The Sr. Finance Analyst performs general accounting and finance function activities. Ensures the accurate compilation, analysis and reporting of accounting and financial data. Assists with ongoing Sarbanes-Oxley compliance. Provides line functions with business planning and analytical support. This position reports to the Director of Finance.

Primary Responsibilities:

• Complete the month-end close process for specific line function - G&A and corporate activities.
• Complete the quarterly budgeting and forecasting process for specific line function.
• Assist with SEC reporting (annual 10-K, quarterly 10-Q and other periodic filings).
• Ensures compliance with US GAAP and provides support for SOX testing and the annual audit process.
• Research technical accounting and reporting topics.
• Assist with ad-hoc projects supporting the Director of Finance and Controller.

Position Requirements:

• Minimum 2 years corporate finance and/or public auditing experience.
• BA/BS business/accounting/finance or other applicable business discipline.
• CPA with public accounting experience preferred with a Big 4 accounting firm.
• Strong understanding of US GAAP, SOX 404 compliance and internal controls.
• Expert proficiency with excel.
• Life Sciences a plus.

Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship.

The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.

If you reside in a state or locality with enacted pay transparency laws, you are entitled to request and receive additional details regarding compensation and benefits. For assistance, please contact us at 2 between 8:00 AM and 5:30 PM ET, Monday through Friday.

Job Title: Freelance Account Director

Location: NYC (hybrid in office)

Start Date: ASAP

Contract hours & length: 40 hours per week for 3 months; temp to hire & extension options

Meet is excited to be partnering with a boutique, independent healthcare advertising agency in search of a talented Freelance Account Director to join their team! They’re seeking someone to support the team in developing materials and responses for an active RFP and help manage launch planning activities with blended HCP & DTC experience. The ideal candidate is NYC-based and available to start immediately.

Skills Required:

• Must be local to commute to the NYC office on a hybrid basis
• * years of experience in a pharmaceutical advertising agency setting required

About the Role

The candidate will support technical documentation required for BLA submission, and ensure the QC organization is inspection ready. This position will also coordinate QC schedules, resource allocation, and testing timelines critical for successful BLA submission.

Responsibilities

• Support preparation and review of technical reports and QC documentation required for the BLA, ensuring timely completion and regulatory accuracy.
• Create, maintain, and monitor QC testing trackers, documenting tests, timelines, assigned analysts, sample workflows, and status updates.
• Facilitate and maintain a resource loading tracker, aligning personnel capacity with sample testing volume to ensure on-time data generation for the BLA.
• Escalate resource gaps, workflow delays, or testing challenges that could impact critical milestones.
• Support method transfer and method validation troubleshooting to ensure analytical readiness for BLA submission.
• Lead the establishment and maintenance of a stability program, ensuring data availability for regulatory filing.
• Participate in internal and external GMP audits, ensuring QC operations meet all regulatory expectations.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Biology, required
• 5+ years of experience in an FDA-regulated pharmaceutical with demonstrated experience supporting major regulatory submissions (e.g., BLA, NDA, MAA).
• 5+ years of experience in analytical chemistry methods including HPLC, UPLC, GC, TOC, and related instrumentation.
• Strong working knowledge of USP/EP, cGMP, EU GMP, and analytical compliance requirements.
• Proven experience tracking testing deliverables, coordinating QC schedules

Preferred Skills

• Technical writing expertise, including investigations, method documents, validation protocols/reports, and change control assessments.
• Ability to prioritize multiple deliverables and manage time effectively in a high-pressure, deadline-driven environment, especially in support of regulatory filing timelines.

Kelly is hiring a Quality Supervisor for one of our food manufacturing clients in Affton, MO

Reporting to: Quality Manager

Reason for opening: Site growth. Historically, 1 Quality Supervisor has overseen both South and North Buildings. This individual will be dedicated to the North Building overseeing Quality Technicians and Quality Operations

Overview: The role involves significant documentation review (25-30%), people management/meetings (20%), on-floor support and issue resolution (40%), and miscellaneous tasks (10%).

Shift: M - F day shift, with the need for flexibility to work weekends as required.

• Demanding workload of 50 - 55 hours per week. Candidates seeking only 40 hours a week are not a fit

Salary Range: $90,000 - $110,000K

Qualifications:

• Candidates must have a food safety background (PCQI) and experience supervising direct reports, ideally 3-5 quality technicians.
• A strong preference exists for candidates with food manufacturing experience over pharmaceutical, as regulatory requirements differ.

Job Overview:

This position reports to the Quality Assurance Manager and will directly supervise employees in the QA Lab. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees.

The Quality Assurance Supervisor will be responsible for implementation and continuous improvement of quality programs in Affton facility.

Requirements: • Develop and maintain procedures which assure Food Safety and Quality.

• Responsible for identifying and resolving problems.

• Implements various components of quality assurance program comprised of data analysis, systems evaluation, product assessment and quality technology.

• Directs inspection of hardware and systems audit to ensure proper application of management system procedures.

• Directs and participates in completion of environmental monitoring and positive release requirement.

• Responsible for raw material, in process and finished goods quality inspection.

• Directs and advises personnel in special test procedures to analyze components and physical properties of product materials.

• Compiles and analyzes test information to determine operating efficiency of process or equipment and to diagnose malfunctions.

• Investigates complaints on existing products and responds to vendor or customer.

• Establishes or adjusts work procedures to meet testing schedules.

• Maintains and revises all SOP’s, SSOP’s and forms in the document management system.

• Supports commissioning, qualification and validation for capital projects.

• Trains all personnel on programs related to implementation of the quality and food safety management system including on-boarding, annual and ad hoc training.

• Oversees sanitation responsibilities as assigned.

• Participates in and supports corporate and plant initiatives including GMP, HACCP, SQF, GQMS, KMM, LIMS and others as assigned.

• Participation and /or facilitation as identified in customer, regulatory and 3rd party audits. Quality Supervisor

• The position has the authority to observe, review, lead and take initiative/action for quality activities in site, supplier, and customer activities, with proper notification to senior management of each.

• The position has the authority to develop, implement and audit programs directly related to quality and assigned projects.

• The position has the authority to manage the quality activities performed by personnel in alternate functional areas in conjunction with the respective managers.

• Other duties may be assigned.

Operations Technician I

Location: Rahway, NJ Work Environment: On-Site

Job Summary

The Operations Technician I is an entry-level professional responsible for executing technical tasks and supporting critical operational activities. This role is essential to the timely packaging, labeling, warehousing, and distribution of bulk and finished clinical materials.

The successful candidate will ensure full compliance with Quality-related aspects of Global Clinical Supply Operations, including inventory management, SOP authoring, and supporting internal inspections.

Key Responsibilities

Clinical Supply & Logistics

• Perform primary and secondary packaging of drug products, biologics, and vaccines.
• Execute distribution activities, including order processing and drug picking, packing, and shipping.
• Manage all tasks related to clinical label printing and production.
• Oversee warehousing activities, including bulk component inventory movement and accuracy.
• Maintain optimal inventory levels for consumables through proactive ordering.

Compliance & Quality Assurance

• Maintain cGMP and safety training to site requirements at all times.
• Author or revise Standard Operating Procedures (SOPs) and support batch record reconciliation.
• Support investigations into root causes and assist in the creation of Corrective and Preventative Actions (CAPAs).
• Act as a Subject Matter Expert (SME) during internal or external audits from regulatory agencies and safety bodies.

Technical Operations

• Operate within cold vaults, walk-in CTUs, and stand-up CTUs.
• Execute assigned technical tasks with a high degree of reliability and follow-through.
• Utilize SAP for technical activities and maintain accurate, detailed documentation.
• Engage in creative problem-solving and provide analysis to anticipate technical obstacles.

Qualifications & Skills

Education & Experience

• Bachelor’s degree preferred; candidates with relevant experience will be considered.
• 0–3 years of experience in a related field (or 3+ years of relevant experience for candidates without a degree).
• Experience using and wearing respiratory equipment.
• Training or experience in forklift and pallet jack operation.

Technical Knowledge

• Strong understanding of Good Manufacturing Practice (GMP) principles.
• Knowledge of quality and safety requirements for pharmaceutical packaging and handling.
• SAP experience is highly desired.
• Equipment operation and repair skills.

Physical Requirements

• Ability to repetitively lift, carry, push, and pull up to 50 lbs.

General Competencies

• Exceptional organizational skills and meticulous attention to detail.
• Strong problem-solving and troubleshooting abilities.
• Ability to quickly learn new systems and demonstrate in-depth knowledge of GMP processes.

Key Responsibilities

• Conduct QC testing for raw materials, in-process samples, finished products, and stability samples. Develop and execute laboratory work plans and testing schedules. Review and interpret analytical data, identify trends, and troubleshoot technical issues.
• Author and review technical documents including protocols, analytical methods, reports, and SOPs.
• Utilize laboratory electronic systems such as LIMS, QMS, CDMS, and ELN.
• Conduct and document laboratory investigations, deviations, and root cause analysis. Ensure data integrity and compliance with cGMP, ICH guidelines, and regulatory requirements.
• Review laboratory data and documentation for accuracy, completeness, and regulatory compliance.
• Support laboratory operations, equipment maintenance, and general lab organization.

Qualifications

• MS in Chemistry, Analytical Chemistry, or related field with 2+ years of experience, or BS in Chemistry, Analytical Chemistry, or related field with 4+ years of experience.
• Experience working in cGMP-regulated pharmaceutical
• 4 years of experience in HPLC, UPLC, dissolution, GC, Karl Fischer, and experience with the Empower system; LIMS, and Master Control experience preferred.
• Familiarity with ICH guidelines and regulatory requirements.
• Strong analytical, documentation, and problem-solving skills.

Global Product Quality Specialist

12-month Contract

Remote- EST Hours

Responsibilities:

• Quality Systems Support:
• Work collaboratively with internal and external partners to ensure deviations, investigations, OOS/OOTs, CAPAs and change controls adhere to quality system requirements and current GMP expectations.
• Support of regulatory submissions, annual reports and preparation of annual product quality reviews
• Inspection readiness for Internal and external audits
• Compile metrics for continuous improvement initiatives
• Assist in the writing of Quality Agreements
• Documentation Review:
• Review of API, DP and Packaging batch records
• Review of test methods, component specifications, validation protocols/reports, BOM
• Review of stability protocols and reports, and data in LIMS
• Operational QA Support:
• Work with external CDMOs and laboratories in the review of quality events, change controls, data review, and batch record documentation
• Creates and/or ensures on-time closure of Quality records in TrackWise Digital (batch records, deviations, change controls, investigations, CAPAs and effectiveness checks)
• Uploads and routes documents for approval in the company Electric Documentation Management System (Veeva) and DocuSign
• Project QA Support:
• Represent quality on cross-functional teams and provide support to ensure compliance with GMPs, FDA expectations, product specific requirements, and company standards are consistently met
• Ensure the review and release of clinical and commercial lots meet expected timelines to maintain an uninterrupted product supply

Qualifications:

• BS Degree in scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering) or equivalent experience in a GMP-regulated environment
• 4 to 7 years of experience working within Pharmaceutical Quality, Engineering, Production or QC/Analytical Development function
• Ability to author and/or provide clear, concise, and technically accurate feedback on GMP documents (SOPs, deviations, CAPAs, investigations, protocols, reports)
• Attention to detail required to perform thorough document review, accurate data verification, and consistent application of right first time principles
• Working knowledge of ICH guidelines (e.g., Q7/Q8/Q9/Q10, Q12) and 21 CFR Parts 210/211 and/or EU GMPs, with the ability to apply these requirements to real-world manufacturing, testing, documentation, and release processes
• Experience with at least two QMS elements (e.g. Deviation, CAPA, Change Control)
• Strong written and verbal communication skills; ability to collaborate with cross-functional teams
• Proficiency with MS 365 (Word, Excel, PowerPoint, SharePoint/Teams).
• Experience with electronic QMS/eDMS (TrackWise, Veeva, LIMS) systems is a plus.

Pharmacovigilance Scientist

3-month contract

Hybrid in Waltham, MA

We’re seeking a Senior PV Scientist to support safety and risk management activities for investigational and marketed products within an oncology portfolio. This role partners closely with the Safety Physician to evaluate, interpret, and communicate product safety data while ensuring compliance with global regulations.

Key Responsibilities:

• Lead safety analytics and signal management for assigned products
• Author and coordinate aggregate safety reports (DSURs, PSURs, PADERs)
• Review and contribute to clinical and regulatory documents (protocols, IBs, CRFs, ICFs)
• Manage safety queries, data analyses, and health hazard evaluations
• Collaborate cross-functionally with Safety, Biostatistics, Clinical, and Regulatory teams
• Support process improvement initiatives and ensure compliance with PV standards

Qualifications:

• Advanced degree (PharmD, RN, MD, PhD, MPH, NP, or equivalent)
• 5+ years of relevant medical, scientific, or pharmaceutical experience, including 3+ years in pharmacovigilance or drug safety
• Must have experience in mental health or neurology
• Strong analytical, communication, and project management skills
• Proficiency in Excel, PowerPoint, and safety database systems (e.g., Argus)