Schott Pharma Jobs in Usa

The Sr. Project Engineer will support manufacturing operations with the introduction of new processing, packaging or facility fixed capital assets. Identify, develop and implement process improvements. They will also serve as a technical resource for designing and implementing technical solutions. Accountable for timely delivery of project engineering deliverables in a multi-functional environment. This could involve the relocation and optimization of the existing fixed asset base and/or the purchase of new fixed assets.

Essential Duties and Key Responsibilities:

• Managing capital projects from initiation to delivery utilizing engineering project management processes and procedures
• Adhering to regulations, industry best practices, and company engineering standards.
• Ensuring the successful completion of all project phases; Initiating, Planning, Executing, Controlling, & Closing.
• Develop and manage Resource Plans throughout the project lifetime.
• Develop and manage Communication Plans with all stakeholders throughout the lifetime of the project.
• Develop and manage Budget & Cost plans throughout the project lifetime.
• Providing technical solutions, design support, and equipment troubleshooting assistance to operations.
• Recommending and implementing continuous improvement projects and developing the necessary justifications and return on investment to drive these improvements.
• Developing knowledge mastery in new systems to train and coach plant engineers and maintenance staff with thorough transfer of knowledge and documentations.
• Ability to multi-task and work in a fast-paced and dynamic manner with quick response to change of direction.
• Proposing and implementing work processes, procedures and technical resources in accordance with the Engineering Policy.

Qualifications:

• BS Degree in Mechanical, Chemical, or Electrical.
• Minimum 8 - 10 years Project Engineering or Management Experience in a fast-paced manufacturing setting with experience in Food & Beverage, or Pharma manufacturing.
• Strong experience in capital project management utilizing standards and projects delivery through Initiation, planning, and execution.
• Skilled in developing DQ, FAT, CQV, Ramp up analysis, and other project management protocols.
• PE or SrPE, plus PMP certification preferred.
• Proficient in MS Office especially Excel and Microsoft Project, and ability to use CAD to develop and edit system designs and machine layouts. Ability to read electrical schematics, P&ID, construction drawings, and other technical documents.
• Demonstrated successful experience in a beverage, aseptic and/or food manufacturing environment.
• Understanding of financial analysis, relevant business KPI's and CAPEX budgeting preparation and tracking within approved budgets.

Position: Associate Director, Clinical Quality Compliance

Location: Bedford, MA (On-site 3 days/week)

Length: 6 Month Contract

Please no agencies. Direct employees currently authorized to work in the United States – no sponsorship available.

Job Description:

The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. This person will support the clinical study teams towards ensuring compliance with global regulations (e.g., FDA, EMA, etc.) and will be required to contribute to developing the right strategies for the design and execution of all clinical and bioanalytical studies. This person will be responsible for establishing our clients inspections management program for GCP inspections and expected to be influential towards maturing the quality culture and help reach a sustained state of inspection readiness. This person will contribute to and execute the Clinical Quality Management Plan for compliance and risk monitoring for all the clinical studies. This person is required to contribute to establishing a scalable Quality Management System that is always ready for inspection. This role requires the person to identify and effectively communicate compliance risks and assist with developing sound strategies and drive action plans to mitigate risks.

Essential Duties and Responsibilities:

• Contribute to the development and maintenance of procedures for the GCP/ GCLP managed activities.
• Partner closely with members of the Clinical Development team to support the successful and compliant execution of clinical studies to meet regulatory requirements, guidelines, internal policies, and procedures.
• Develop and maintain integrated data-driven risk-based quality management plans to monitor the health of compliance.
• Participate in the development of GCP/GLP auditing strategies.
• Support investigations into scientific misconduct and/or serious breach of GCP. Partner with CROs and the clinical study team to analyze investigation findings to identify root/probable cause. Ensure adequate investigation, documentation, and implementation of appropriate CAPAs. Assure timely reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
• Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely regulatory submissions.
• Establish the GCP inspection preparation program and facilitate mock PAI inspections as necessary.

Qualifications:

• BS/BA, MS or PhD and a minimum of 10 years’ experience, respectively, in Biotech, Pharma or CRO.
• Working knowledge of relevant FDA, EU, ICH GCP / GCLP regulations and guidelines.
• Proficient auditing skills with the ability to identify risks based on objective evidence and communicate findings in a sound and factual manner.
• Ability to work autonomously, effectively manage time and deliver results on time.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• Conflict resolution/management and negotiation skills.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent organizational, interpersonal, verbal, and written communication skills.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Come see why DPC has achieved:

• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.
• Voted ‘Best Staffing Firm to Temp/Contract For’ seven times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!

# 18352

The Director Quality Affairs is in charge of providing subject matter expertise on matters related to FDA regulatory compliance requirements, as well as leading the growth and responsibilities of the Quality Department. Responsible for maintaining the company’s Quality Management System’s (QMS). The Director represents the company in key stakeholder and strategy meetings on all quality matters related the company’s assets (development and manufacturing), including meetings with executive leadership, meetings with FDA and other regulators, and working with development and manufacturing partners. This role combines scientific, regulatory, and business knowledge to assure that products are developed within GXP compliance while meeting the company’s strategic goals.

Essential Duties and Responsibilities:

Quality

• Manages GXP quality activities.
• Builds on the company’s Quality Management System; formulates the company’s GMP, GLP and GCP compliance strategies and provides advice and support for clinical development programs.
• Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, storage and distribution sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
• Oversee the QA reviews of GMP manufacturing and packaging batch records, product release and stability testing, validation reports, and essential clinical study documents.
• Assess all GMP compliance risks and develop and implement risk mitigation measures.
• Develops and implements standards, policies and procedures for GMP, GLP and GCP compliance.
• Partners with CMC, Clinical Development and Clinical Operations to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance.
• Participates in the evaluation and selection of contract manufacturing sites, analytical testing sites, storage and distribution, CROs and other service providers used to support the clinical development programs.

Operations

• As the company grows, build a strong quality team to meet the needs of the business.
• Manage quality vendors.
• Develop and mentor quality staff/personnel.

Supervisory Responsibilities:

• Yes, in the future

Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:

• Over 10 years of progressive advancement within GMP, GLP and GCP in the pharmaceutical /biotech industry.
• A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines.
• Ability to speak and interact with a diverse group of individuals on technical and business topics.
• Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena.
• Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization.
• Strong presentation, written and verbal communication skills; a clear communicator who can influence stakeholders effectively, both internally and externally.
• Proven ability to lead and manage complex global projects to successful completion.
• Flexibility/agility to respond to Renew’s evolving business needs.
• Strong ability to influence and gain credibility with both internal and external key stakeholders.
• Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex Quality issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
• Ability to build collaborative relationships both internally and externally.
• Ability to inspire, motivate and develop regulatory and quality teams.
• Ability to prioritize and handle multiple projects simultaneously.
• Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with scientists, managers, peers, and staff.

Education and/or Experience:

• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree preferred.
• 10 +yrs. of industry experience (biotech/pharma/ CRO) with at least 8 years of QA experience
• Experience in ANDA and NDA FDA inspections (sponsor, vendor and sites)
• Strong understanding of ICH, GMP, GCP and relevant regulatory requirements
• Strong operations and management skills with attention to detail
• Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project

Equal opportunity employer

Sr. Quality Control & Sample Management Specialist

Our client is looking for an experienced QC and sample management professional to support high‑quality data generation within our Translational DMPK and Clinical Pharmacology team. This role ensures accuracy, compliance, and smooth sample lifecycle management across internal and external studies.

Responsibilities

• QC review of bioanalytical data (LC‑MS/MS, ELISA, qPCR) and study documentation from internal teams and CROs
• Manage and review scientific documents in SharePoint
• Format internal reports and provide templates to CROs
• QC review of packing slips, manifests, and critical reagent documentation
• Contribute to drafting and editing bioanalytical lab guidelines
• Routine QC of Electronic Lab Notebooks
• Audit finalized reports and maintain errata
• Use LIMS (LabVantage) for sample receipt, tracking, aliquoting, storage, shipping, and disposal

Requirements

• Bachelor’s degree in a scientific or healthcare field
• 5+ years QC experience in pharma, biotech, or CRO environments
• Proficiency with LIMS (LabVantage preferred) and electronic notebooks
• Strong understanding of GxP regulations
• Excellent attention to detail, communication, and organizational skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Familiarity with bioanalytical assays is a plus

Outside Sales Representative – Regenerative Medicine (Wasatch Front)

Cellcura Sciences

Utah (Wasatch Front focus · in-state only)

 Commission role with $6,000/month base (up to 6 months) + uncapped upside

About Cellcura Sciences

Cellcura Sciences is a Utah-based life sciences company advancing regenerative medicine.

Our flagship product:

• Terminally irradiated, filtered amniotic fluid
• One-year shelf life
• Stored at 2–30°C (simple logistics)

We’re building a lean, execution-focused commercial team and are looking for an outside sales rep who wants to be in the field, build real relationships, and grow with an early-stage company.

The Role

This is a hands-on outside sales role focused on execution

You’ll carry out a defined sales strategy by calling on med spas, clinics, physicians, and regenerative medicine practices across the Wasatch Front. This role is ideal for someone who is energetic, coachable, interested in health and wellness, and motivated by performance-based compensation.

You don’t need to be a subject-matter expert on day one. We’ll train you. You do need to be curious and comfortable learning basic biology and regenerative medicine concepts.

This role can be structured as W-2 or 1099, depending on experience and fit.

What You’ll Do

• Execute a defined sales strategy across the Wasatch Front
• Prospect, schedule, and conduct in-person sales calls with:
• Med Spas
• Clinics
• Physicians
• Surgical and regenerative medicine practices
• Build trust-based relationships with physicians, practice managers, and clinical staff
• Clearly communicate product benefits and differentiation
• Learn and confidently present foundational concepts related to:
• Amniotic fluid
• Regenerative biology
• Support product evaluations, onboarding, and early adoption
• Maintain CRM activity and share field feedback with leadership
• Represent Cellcura Sciences professionally in all clinical settings

Who We’re Looking For

• 1–5 years of outside sales experience
• (medical, device, biologics, pharma, or adjacent B2B preferred)
• Strong interest in health, wellness, and regenerative medicine
• Basic understanding of biology, anatomy, or cell science
• (formal education or self-taught)
• Coachable and comfortable learning scientific concepts
• High energy, self-motivated, and disciplined with territory management
• Professional appearance and demeanor appropriate for physician-facing roles
• Strong communication and relationship-building skills
• Valid driver’s license and ability to travel locally within the Wasatch Front

Compensation & Structure

• Commission-based compensation with uncapped upside
• $4,000/month draw for up to 6 months during ramp up
• Continued employment expected to exceed draw through commissions by month six
• W-2 or 1099 structure depending on experience and fit
• No out-of-state travel required

Why Join Cellcura Sciences?

• Differentiated regenerative product with strong market demand
• Room temperature storage for simple logistics compared to many biologics
• Direct access to founders and leadership
• Opportunity to grow as the commercial team expands
• Performance-based upside without corporate bureaucracy

How to Apply

Submit your resume along with a brief note covering:

• Relevant sales experience
• Interest in regenerative medicine or health sciences
• Any biology, science, or medical background (formal or informal)

Role Overview

The Key Account Manager (KAM) is responsible for managing and expanding Pion’s most

strategic customer relationships within the Boston market. This role is central to the

company’s growth strategy and carries meaningful ownership over revenue performance,

account expansion and long-term customer value.

The KAM operates with a high degree of autonomy and accountability, working in a

performance-driven environment where accurate forecasting, structured account

planning, and disciplined execution are essential. This is not a transactional sales role - it

requires strategic thinking, scientific credibility and operational rigor.

Key Responsibilities

Strategic Account Management

 Own and execute comprehensive account plans aligned to company growth targets

 Build deep, multi-level relationships across R&D, Analytical, CMC and Procurement

 Understand customer workflows, strategic priorities, and long-term pipelines

 Position Pion as a long-term partner through value-based, consultative engagement

 Identify expansion opportunities tied to new applications, enhanced products and

evolving customer needs

Sales Execution & Growth

 Deliver against defined revenue and growth objectives for assigned territory

 Manage complex sales cycles involving capital equipment, consumables and

services

 Maintain disciplined pipeline management, opportunity qualification and

forecasting

 Ensure CRM accuracy and timely updates to support operational planning and

leadership visibility

 Set and manage customer expectations around manufacturing schedules, lead

times and delivery constraints

Operational Excellence & Rigor

 Operate with a high level of structure, accountability and follow-through

 Partner closely with Operations, Manufacturing, Applications, and Service to drive

predictable outcomes

 Proactively identify risks and constraints, escalating appropriately and early

 Contribute to continuous improvement of sales processes, tools, and cadence

Customer Advocacy & Internal Collaboration

 Serve as the primary commercial owner for assigned territory accounts

 Coordinate internal resources to ensure successful installations, adoption and

ongoing value realization

 Act as the voice of the customer, providing actionable feedback to Product and

Leadership teams

 Navigate escalations and competitive pressures with professionalism and clarity

Market & Competitive Insight

 Maintain strong awareness of regional market dynamics, competitors and emerging

technologies

 Represent Pion customer meetings, scientific forums and industry events

 Identify high-growth opportunities within pharma, biotech, CDMOs and academic

institutions in the Boston ecosystem

Qualifications & Experience

Required

 Advanced degree in Chemistry, Pharmaceutical Sciences, Engineering or a related

scientific discipline preferred

 5+ years of experience in life sciences sales

 Demonstrated success managing complex, high-value strategic accounts

 Strong understanding of drug development workflows

 Ability to operate e􀆯ectively in a performance-driven, growth-oriented environment

 Strong organizational skills with a track record of operational discipline and

execution

 Willingness to travel regionally and occasionally nationally

Preferred

 Experience selling analytical instrumentation or pharmaceutical enabling

technologies

 Familiarity with capital equipment sales cycles

 MBA or advanced scientific degree

 Experience working cross-functionally within a global organization

What Success Looks Like

 Measurable contribution to Pion’s strategic growth targets

 Strong penetration and expansion within assigned key accounts

 Accurate forecasting and disciplined account management

 High customer trust and long-term partnership development

 Consistent demonstration of operational excellence and accountability

Why Join Pion

 Be part of a respected scientific company entering an exciting new growth phase

 Work with enhanced technologies that are expanding Pion’s impact in drug

development

 Operate in a role where individual performance directly influences company

success

 Collaborate with a knowledgeable, committed team focused on execution and

results

 Competitive compensation, incentive plan and benefits