Schott Pharma Jobs in Usa

Pay $37-$39 per hour DOE

Seeking a tactical, detail-oriented Quality professional to support external-facing quality records related to raw material suppliers. The ideal candidate will have 3-5 years of hands-on experience managing deviations, change controls, and CAPAs using systems like TrackWise or Veeva. A strong grasp of root cause analysis and investigation review is essential. Candidates should have a background in biotech or medical device industries, with the ability to operate in a fast-paced, remote environment. Bachelors Degree is best but associate-degree holders with deep experience (10+ years) will be considered. Overqualified individuals (e.g., former directors or PhDs) and those without relevant quality records experience should not be submitted.

Quality records experience working with suppliers would be a home run candidate.

Basic project management skills required.

The Specialist Manufacturing is expected to own and execute under minor supervision all the processes related to deviations (minor and majors), Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This Specialist Manufacturing will act as the External Supply representative across functional teams and drive closure of quality records in a timely manner. The Specialist Manufacturing, External Supply owns and manages quality records originating from manufacturing sites across the network. In addition, this role will be the main External Supply quality record owner point of contact for New Albany, OH site.

Responsibilities:

- Address and close quality records (Deviations, Corrective and Preventive Actions (CAPAs), CAPA-Effectiveness Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements.

- Monitors and investigate deviations owned by External Supply and implements corrective / preventive actions. Partner cross-functionally across the site to ensure maturity and execution of robust Deviations / CAPA process

- Build and present quality records summaries for Senior Management review. Provide timely and comprehensive process and status updates to senior management

- Support New Albany, OH site as the external supply quality record owner main point of contact and collaborates with the site and technical teams to evaluate observed supplier related defects.

POSITION SUMMARY: The Sr. EHS Specialist is responsible for complex technical work within a range of EHS disciplines.The Sr. EHS Specialist will assist and support to the Associate Director of EHS in the development, implementation, and monitoring of the site’s EHS programs designed to protect the health, safety, and well-being of all Ash Stevens employees, visitors, contractors, the Community, and the local environment as well as compliance with all relevant EHS regulations and best industry practices.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, MIOSHA, MI DEQ, and related EHS procedures, policies, and practices.
• Consistent support of Ash Stevens’ mission and values.
• Identify and protect the original technical information as part of the company property.

KEY ACCOUNTABILTIES:

• With limited supervision, assist and support the Associate Director of EHS with the development, implementation, and continuous improvement of all EHS management systems and programs.
• Support business plan KRAs/goals and develop and monitor to ensure goals are achieved.
• Develop implement, document, and periodically review Company training programs related to EHS to protect workers and satisfy regulatory and site requirements.
• Develop, review, approve and implement SOPs, Work Instructions, and all other EHS documents.
• Support site management with incident investigations, root cause analyses, and assignment & tracking of CAPAs as needed.
• Partner closely with internal cross-functional stakeholders to communicate, secure support, and inform the facility of EHS compliance risks and gain alignment on EHS initiatives and priorities.
• Ensure that the site complies with applicable EHS regulations and Company requirements, guidelines, and policies and takes the necessary steps to prevent non-conformances.
• Ensure that all EHS reporting, both internally and externally, is conducted timely and accurately.
• Assist with safety evaluations and risk assessments (JHA, PHAs, HAZOPs, FMEAs, PSSRs, etc.) of new products, processes, facilities, and equipment and recommend CAPAs to improve safety performance.
• Provide technical support for EHS programs (LOTOTO, Hazcom, Respiratory Protection, Chemical Hygiene, etc.)
• Assist with the development of annual EHS KRAs, goals, plans, objectives, and budget as directed by the AD.
• Complete requisite environmental reporting (Tier 2, biennial hazardous waste, air emissions, TRI, and stormwater) as directed by AD.
• Reporting injury/illness data electronically to OSHA & generating and posting requisite site reports
• Assigning and managing EHS education and training using MasterControl software system.
• Conducing new hire orientation (NHO) safety training and education as needed.
• Maintain and control site SDSs for RMs, SMs, IPs, and FPs per Hazcom Standards.
• Conduct qualitative/quantitative exposure assessments for hazardous materials and HPAPIs.
• Assessing site compliance with corporate policies/guidelines and federal, state, and local regulations through periodic workplace audits and walkthroughs (Gemba walks).
• Responsible for guiding Site Safety Committee (SSC) activities and initiatives.
• Work closely with Facilities, Engineering, Manufacturing, and Laboratory teams to ensure contractors and subcontractors work in compliance with all site EHS requirements (Safe Work Permits, PRCS entries, LOTOTO, hot work, etc.)

EDUCATION/EXPERIENCE:

• Bachelor’s degree in EHS, Engineering, Chemistry, Industrial Hygiene, or similar degree required.
• Master’s degree in EHS or related field preferred.
• Minimum of 5 years of EHS experience in a pharmaceutical manufacturing environment preferred
• EHS Certifications are a plus (CSP, CIH, QEP, CHMM)
• Sustainability & ESG experience are a plus.
• SDS authoring
• HPAPI containment and isolation equipment and practices.

JOB COMPETENCIES

• Excellent organizational and planning skills.
• Strong leadership and ability to influence all levels of employees.
• Strong problem solving/troubleshooting skills.
• Strong auditing and risk-assessment skills.
• Ability to self-lead work tasks to completion.
• Proficient in MS Office (Word, Visio, PowerPoint, & Excel), Emission Master, SAP, and Smartsheet.
• Strong written, verbal, and interpersonal communication skills.
• Excellent presentation and adult learning skills.
• Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
• Self-motivated and detail oriented.

Scientist II

Location: Worcester, MA

Work Arrangement: 100% onsite

Contract Duration: 12 months

Overview

We are seeking a highly motivated and talented Scientist II to join our In Vivo Antibody Discovery and Molecular Core team in Worcester, MA. This is a newly created role driven by increased workload, supporting a team of six scientists.

This R&D-focused position centers on high-throughput next generation sequencing (NGS), primarily working with human cells. The role involves upstream processing, including working with primary cells (p cells), DNA extraction, sequencing preparation, and data analysis, with results shared with downstream scientists.

Key Responsibilities

Experimental Design & Execution

• Independently design, execute, and interpret experiments utilizing microfluidics to amplify heavy and light chain genes and generate DNA libraries for deep sequencing of single B cells captured in droplet emulsions
• Understand project objectives and adapt experimental plans as needed while meeting timelines

Molecular Techniques

• Perform RNA isolation and DNA purification
• Amplify antibody heavy- and light-chain variable regions from single cells or lysates
• Prepare and submit DNA libraries for next generation sequencing (MiSeq/MiSeq i100)

Bioinformatics & Data Analysis

• Conduct sequencing data analysis of cells
• Perform in silico antibody genetic analysis and data visualization using standard and custom bioinformatics tools
• Utilize coding/data analysis at a basic to intermediate level (preferred)

Collaboration

• Present and discuss experimental findings with cross-functional teams
• Support multiple programs across the in vivo antibody discovery portfolio
• Work both independently and collaboratively while managing multiple projects

Qualifications

• 3–5 years of experience
• Hands-on experience with DNA sequencing (Illumina) – required
• Microfluidic experience – required
• Experience working with next generation sequencing (NGS)
• Molecular biology expertise
• DNA/RNA purification experience
• Primary cell (p cell) experience
• Data analysis background – preferred
• Basic to intermediate coding/data experience – preferred

Education

• Bachelor’s or Master’s degree required
• PhD is overqualified (OQ)

Required Skills & Experience

• Master’s degree in biology, immunology, cell/molecular biology, or related discipline with experience in single B cell sequencing research and 2+ years of relevant experience (MS)
• Demonstrated hands-on expertise in droplet microfluidics of single B cells and next generation sequencing of IgG variable heavy and light chains
• Familiarity with next generation sequencing platforms (Illumina MiSeq and MiSeq i100) and B cell genetic data analysis software/databases (FLASH, IgBlast, Usearch, IMGT)
• Experience in reverse transcription, RNA/DNA isolation and purification, overlap extension PCR, primer design, cDNA library generation, and gel electrophoresis
• Protein and cell detection methods experience (ELISA and/or FACS) – preferred

Additional Details

• Reason for Need: New role due to increased workload
• Team Size: 6

• Operation of packaging equipment (e.g.: labelers, pick and place, heat tunnel, vision systems, forklift, etc.)
• Inspect product accurately and efficiently to meet quality guidelines.
• Perform equipment change-over, set-up.
• Responsible for initial troubleshooting for packaging equipment issues (e.g. Labelers, Pick and place, heat tunnel, etc.)
• Ensure that proper cGMP documentation is follow for completeness and adherence to our procedures and in a timely manner.
• Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
• Preparation of QA Line clearances (e.g. Small volume line).
• Maintains a safe, clean and organized work environment.
• Maintains facilities and equipment as required by Standard Operating Procedures.
• Cross-training in other areas within the department as require to meet business needs.
• Other duties as assigned by the Shift Line Leader or Supervisor

Office Assistant

Location: New Providence, New Jersey

Employment Type: Contractor to Permanent (3–6 month trial period)

Work Schedule: 4–5 days per week in office, with optional remote work on Fridays

About the Role

We are seeking a proactive and organized Office Assistant to support daily office operations and provide administrative support to leadership. This role combines office management, employee engagement, and executive assistance, requiring someone who thrives in a small, dynamic company environment. The ideal candidate is flexible, solution-oriented, and enjoys creating a positive and collaborative work atmosphere.

Key Responsibilities

Office Support

• Support daily office functions and create a welcoming environment for employees and visitors.
• Serve as the main point of contact at reception: greet guests, answer office questions, manage mail, and handle shipments.
• Be prepared to handle regulatory visits appropriately.
• Assist employees with planning office meetings, including site coordination and catering orders.
• Manage office vendors, including equipment maintenance and supply orders.
• Coordinate with building management on issues like temperature, cleaning, and other facilities needs.
• Create new hire badges, conduct office tours, and review office procedures.
• Assist in organizing company-wide events, executive meetings, off-sites, office lunches, team activities, and holiday parties.
• Foster a positive and collaborative office culture.
• Support ad-hoc projects and tasks as needed.

Administrative Support

• Provide proactive administrative support to leadership, including calendar management and resolving scheduling conflicts.
• Coordinate domestic and international travel; assist with expense reporting.
• Schedule recurring meetings, prepare agendas, and distribute meeting materials.
• Manage purchase orders, process invoices, and assist with financial administration tasks.
• Support recruitment efforts by scheduling interviews, coordinating candidate travel, and providing onsite support.
• Prioritize competing tasks and act proactively to address organizational needs.
• Serve as a versatile team member, contributing to special projects and covering gaps as they arise.
• Anticipate problems, take initiative, and provide solutions before issues escalate.
• Collaborate with other office admin team members to maintain an efficient and positive workplace.

Requirements

Education & Experience

• Bachelor’s degree preferred.
• 5+ years of experience in office coordination/management.
• 2+ years of experience in an administrative support role.
• Experience in pharmaceutical or biotech industries preferred but not required.

Skills & Attributes

• Positive, can-do attitude with a willingness to help others.
• Self-starter with a “roll up your sleeves” mentality.
• Strong written and verbal communication skills.
• Proficient in Microsoft Office, Teams, and advanced Outlook calendar management.
• Excellent interpersonal skills with the ability to build relationships across the organization.
• Highly organized with strong multitasking and prioritization abilities.
• Ability to work independently and collaboratively.
• Trustworthy and discreet with confidential information.
• Flexible and adaptable to handle ad-hoc tasks as needed.
• Able to lift boxes and office supplies over 30 lbs

Our client – a global and growing BioPharma CDMO company needs an Engineering Line Lead with Pharmaceutical Industry experienceat their expanding plant in WA state, Excellent total comp. up to $180K+ with excellent Benefits + Relocation Bonus. Client will sponsor for H1B Visa transfer.

Job Posting # 2705R

Job Title: Engineering Team Lead Overnight Travel: 10%

Location: Spokane, WA

Relocation: YES – Theclient offers a lumpsum bonus for relo assistance.

Compensation:Salary range $120K - $165K+ Annual Bonus (10 %)

Full Benefits: Medical, Vision, Dental, 15 days’ vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info:

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info: Be part of the Plant Engineering group of around 60 technical people. This role will have 3 people reporting under this person and handle all technical aspects for this new line 3 (note 1 + 2 below)

This role will report to the Engineering Manager.

Note 1: The company recently completed installation of their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are expanding again with a 4th line at this growing plant site.

Note 2: The primary focus will be the technical and project engineering aspects of a complete filling line.

Note 3: Client willsupport transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Job Summary:

The Engineering Line Lead position provides leadership, manufacturing support and coordination of the engineering department for the CMO line specific projects.

This position ensures that contract projects, equipment functionality, compliance support, and capital expenditures are executed per Company management initiatives, compliance guidelines, the project management system, and the capital budget schedule.

It is the responsibility of this position to ensure line specific compliance of the CMO equipment and team with state, local, and federal regulations.

This position ensures operations and projects are carried out under adherence to GEPs and cGMPs.

Job Functions and applications in cGMP settings.

1. Provide technical oversight and leadership to the engineering team roles responsible for their area of responsibility within the CMO Business Unit.
2. Drive technical improvements and internal/external responses to equipment and facility observations.
3. Management of the assigned capital project schedules and budgets.
4. Assign and oversee engineering projects including internal capital, compliance, and contract manufacturing.
5. Coordinate and supervise engineering resources to ensure adequate and appropriate staffing for current and upcoming projects.
6. Ensure designated area, equipment and engineering infrastructures are compliant to local, state, federal, and international regulatory agencies.
7. Execute high level projects from conception, consistent with upper management objectives for business growth.
8. Manage and execute facility and equipment updates to meet company growth and economic objectives.
9. Support client audits and technical visits.
10. Effectively communicate project status, constraints and current or potential issues to upper management.

Candidate Must Have:

• Bachelors of Science in Engineering or related technical degree.
• 5+ years of Engineering Experience
• 3+ years of Engineering experience in the BioPharma industry
• 2+ years of Project Engineering/Management experience
• Some Leadership, Supervisory experience over Jr. Engineers, Technicians.
• Facility or Manufacturing Engineering Experience
• MS Office suite (Word, PowerPoint, Excel) experience

Candidate Nice to Have:

• BS in Mechanical, Chemical, Electrical, Manufacturing engineering
• Advanced degree or PE or PMP certification
• Experience with PM Software – MS Project, Design software - AutoCAD & ERP – SAP
• Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
• Interfacing with OEM equipment vendors, Construction/consulting partners

Keywords: Projects, Plant Project, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing, Supervisor, Lead

Manufacturing Engineer II (sterile)

COMPANY: SCHOTT Pharma USA (Lebanon, PA) has been providing advanced solutions and services to the global pharmaceutical and biotechnology industries for over 100 years. SCHOTT Pharma USA offers an extensive and scientifically proven product portfolio including vials, syringes, cartridges and Fast Track Kits, for the safe storage and administration of injectable drugs worldwide.

ATTRACTIVE SKILLS/EXPERIENCES:

• Bachelor’s Degree in Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials Engineering (required)
• Six Sigma Certifications and/or PMP (preferred)
• Experience (4+ years) in a regulated manufacturing setting (Pharma; BioTech; Medical Device; Primary Packaging)
• Experience leading Project/CAPEX (up to $500K)
• Experience with Validation and QMS (URS; FMEA; VMP; IQ/OQ/PQ) - Author/Review protocols/reports, manage deviations/CAPA and change control
• Experience leading new equipment / NPI validations (FAT/SAT; commissioning; start-up)
• Demonstrated knowledge of Lean/CI principles (5S; Kaizen; DMAIC; Root Cause; 5-Why; Fishbone)
• Demonstrated knowledge with SAP, MS Project (Gantt / Critical Path), SolidWorks and Minitab
• Proven knowledge of cGMP and ISO Standards (9001; 15378)
• Demonstrated communication skills (written / oral) including the ability to read/speak English
• Ability and willingness to work in fast-paced, matrix structured organization

SUMMARY / RESPONSIBILITIES: This Manufacturing Engineer II (sterile) will lead validated, compliant CAPEX projects and new product/equipment introductions that improve OEE, reduce scrap, and integrate seamlessly into production, on-time and on-budget. Other potential duties/expectations include (but not limited to)…

• Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholders
• Lead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global Engineering
• Manage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accruals; deliver fiscal year plan on time and on budget
• Prepare and maintain audit ready documentation aligned to US cGMP
• Operate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control Strategy
• Own change controls (local and global)- initiation, risk assessment, execution plan, verification of effectiveness and closure
• Lead/support validation and qualification for equipment, products, processes, etc.
• Integrate into operations; plan trials and downtime, coordinate line readiness/tech transfer, create/update SOPs, define PM requirements and maintenance plans, ensure spares/training are in place
• Support quality investigations
• Drive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle times
• Mentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where needed
• Promote safety and EHS and adhere to all Company policies, procedures and guidelines
• Perform other duties as assigned

Company Description

Bird Dog Pharma helps medical practices seamlessly integrate physician-directed allergy care into their routine clinical workflows, ensuring continuity of care for patients. Focused on empowering practices to address allergy-driven conditions such as asthma, eczema, and sinus complaints, Bird Dog Pharma supports providers with in-office testing, personalized immunotherapy, and operational integration. By simplifying allergy care, we enable physicians to deliver comprehensive treatment within their own offices. Our mission is to make allergy care practical, sustainable, and accessible for healthcare providers.

Role Description

This is a contract, remote position for a Medical Sales Representative. The role involves engaging with medical practices to promote and support the adoption of Bird Dog Pharma's allergy care solutions. Responsibilities include building and maintaining client relationships, educating healthcare professionals on the company's offerings, and identifying opportunities to expand sales territories. The ideal candidate will conduct market research, provide customer service to medical providers, and achieve sales goals while maintaining a consultative approach.

Qualifications

• Proven experience in Medical Sales and a track record of meeting or exceeding sales targets
• Strong Communication and Customer Service skills for building relationships and delivering excellent support
• Knowledge of Medicine and Pharmacy principles, with a focus on allergy care or a related field
• Self-motivated with the ability to work independently in a remote capacity
• Experience working with healthcare professionals or within a clinical environment is preferred
• Strong organizational skills and adaptability to meet the needs of a fast-paced, dynamic role

Company Description

Patrin Pharma, Inc. is a mid-size, growing pharmaceutical company located in a northern Chicago suburb. In business for nearly 20 years, Patrin has been expanding its product portfolio and distribution footprint. As a smaller and agile organization, senior leaders operate with broad scope and direct impact on strategy, growth, and decision-making.

Position Summary

The National Accounts and Trade Relations Manager is responsible for driving revenue growth through strategic management and expansion of distributor, GPO, and trade relationships. This role combines external relationship leadership with strong commercial analytics to optimize sales performance, distribution strategy, and product pull-through. This position partners closely with the contracts and finance team to ensure commercial strategy aligns with pricing execution, contract performance, and margin objectives. This is an on-site position.

Key Responsibilities

Distributor & Trade Relationship Management

• Build and manage relationships with pharmaceutical distributors, GPOs, and other purchasing partners.
• Serve as the primary commercial liaison between Patrin Pharma and trade partners.
• Conduct regular business reviews and planning sessions.
• Communicate proactively with purchasing partners to remain aligned on market shifts, competitive dynamics, and supply considerations.
• Learn and maintain deep knowledge of customer accounts

New Distributor & Channel Expansion

• Identify, evaluate, and pursue new distributor and specialty channel opportunities.
• Lead commercial discussions and onboarding efforts for new trade partners.
• Expand product listings and improve portfolio visibility across distribution networks.
• Support new product launches within distribution channels.

Market & Sales Monitoring and Analysis

• Monitor competition, sales trends, market share, utilization, price competitiveness, and supply issues across all products.
• Review direct sales and chargeback data to assess product pull-through and channel effectiveness.
• Identify revenue growth opportunities and recommend commercial strategies based on data insights.

Contracting & Competitive Positioning

• Lead submission for contracting opportunities including RFP submissions.
• Communicate Patrin’s competitive positioning and value proposition to trade partners.
• Track contract volumes against expected volumes and identify performance gaps.
• Monitor contract lifecycle and performance in collaboration with Pricing.

Cross-Functional Leadership

• Collaborate with Pricing, Finance, and Operations to align revenue and margin goals.
• Provide market intelligence to support pricing decisions.
• Ensure smooth execution of commercial agreements post-negotiation.

Qualifications

• 5–10+ years of experience in pharmaceutical distribution, generics sales, or trade/channel roles.
• Demonstrated experience working directly with distributor category managers and GPO decision-makers.
• Strong understanding of pharmaceutical distribution economics including chargebacks, rebates, and contract structures.
• Proven record of revenue growth and account expansion.
• Strong analytical skills with ability to translate data into commercial action.
• Excellent negotiation and communication skills.
• Experience with a smaller or mid-size company preferred
• Bachelor’s degree in Business, Finance, or related field.