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Sales Training Manager
Wayne, PA

The Sales Training Manager is responsible for all activities concerned with the planning, development and execution of new product launch training, the field sales training program, and various advanced training programs including; competitive selling, customer engagement, and product knowledge.

Responsibilities:

  • Exerts influence on the overall sales training objectives and long-range goals of the organization
  • Lead and manage the design, development and implementation of training materials to include launch workshops, learning modules, customer engagement model, POA / regional meeting materials and agendas
  • Establish objectives and support development and administration of engagement techniques and presentations, product and product applications information, and role play
  • Partner with Marketing and other cross-functional groups to support the launch of new products and sales tools with comprehensive training materials design, develop, and implement
  • Training-related aspects for the national and regional sales meetings
  • Develop and support a division-wide engagement methodology
  • Conduct field travel for personnel assessments, strategic training initiatives, coaching and development of new hires and regional field trainers
  • Attend critical industry conferences to maintain clinical and competitive knowledge so sales training priorities are market relevant
  • Ensure all sales training output is compliant to corporate and promotion guidelines
  • This position reports to the Director, Training & Development, and works closely with field personnel and regional sales trainers

Competencies:

  • 7+ years of related experience with three or more years pharmaceutical sales experience
  • 3+ years of GI sales experience
  • Strong project management skills
  • Proficient in Microsoft Office (i.e. Excel, Word and PowerPoint)
  • Ability to document, organize and communicate with a high attention to detail
  • Excellent written and verbal communication skills
  • Strong analytical and problem solving skills
  • Demonstrated experience with continuous improvement and self-development
  • Exercises tact, discretion and judgment in accordance with legal, ethical and financial standards

Requirement/Qualifications:

  • Corporate Sales Training experience in the pharmaceutical industry
  • GI specialty
  • Proven leadership abilities
  • Knowledge of Adult Learning Principles

NOTE: This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.

NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.

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Executive Assistant
Wayne, PA

Responsible for performing a number of administrative duties to support the Technical Operations group in the pharmaceutical development and manufacturing of Synergy’s pipeline products.  The duties may include scheduling of intra and interdepartmental and external meetings with CMOs and other vendors, tracking and reporting progress across the spectrum of Technical Operations projects and providing reports on key quality and supply chain performance indicators.

Reports to the Senior Vice President, Technical Operations.

Responsibilities:

  • Coordinate communications, including taking calls, responding to emails and interfacing with CMOs and vendors
  • Assist with the logistics and planning of internal and external meetings (reserve rooms, prepare agendas, schedule WebEx and videoconferences, distribute meeting materials, arrange catering, manage slide presentations and prepare meeting materials),
  • Assist with the management of calendars including travel itineraries for Technical Operations Senior Leaders as required.
  • Process expense reports for Tech Ops Leaders
  • Coordinate the interview process for new hires to Technical Operations as requested.
  • Process onboarding requirements for new Technical Operations personnel.
  • Understand and follow standard Technical Operations processes, procedures and SOPs as applicable.
  • Maintain and manage an organized filing system of paper and electronic documents including quality management documents and validation protocols/reports.
  • Execute requisition in SAP
  • Administer BOX and other shared document sites as requested by Technical Operations teams.
  • Provide general assistance to Technical Operations teams for achieving deliverables, including assisting updating project data, flash reports, KPIs, budget updates, agendas, and minutes.

Competencies/Work Style:

  • Ability to prioritize tasks and work in a fast-paced environment
  • Excellent interpersonal and organizational skills
  • Good written and verbal communication skills

Requirement/Qualifications:

  • Minimum of 4+ years of experience as an Executive Assistant reporting directly to senior management
  • Advanced Microsoft Office skills, familiarity with SAP highly desirable, with an ability to become familiar with Synergy-specific programs and software
  • Proficiency in collaboration
  • Strong organizational, project management and problem-solving skills with impeccable multi-tasking abilities
  • Exceptional interpersonal skills
  • Friendly and professional demeanor
  • Experience in GMP manufacturing and/or development environment preferred but not required

NOTE: This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.

NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.

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Program Director
Wayne, PA

Responsible for managing the scope, cost and time of supply chain and quality projects as well as new formulation development projects through the planning, implementation, and closeout phases of the project life cycle. The project director is responsible for providing the knowledge, skills, tools, and techniques to manage project activities throughout the project life cycle. Contributes to the production of high quality Synergy pipeline products by ensuring that all work is done in a manner compliant with cGMPs, SOPs, government regulations and corporate policies and procedures.

Works closely with Supply Chain, Quality and/or Regulatory personnel as well as external research/contract organizations and will participate with a variety of internal and external teams.

Reports to the Senior Vice President, Technical Operations.

Responsibilities:

  • Cross-Functional Teams - coordinate new supply chain and quality project management activities between Technical Operations, R&D, Commercial, Finance, IT, etc. to ensure the timely product launches of domestic and global products to meet Synergy objectives.
  • Project Management - ensures all projects have timelines and that project teams have clear goals, objectives, and milestones consistent with Synergy's objectives and financial goals. Drives continuous improvement of the project management process. Participates in portfolio review and budget process.
  • Communications - Ensures effective collaboration and communication takes place in category and cross-functional organization. Communicates critical issues and resolution plans to Technical Operations management. Publishes meeting agendas, minutes and metrics.
  • Decision Making - develops solutions to complex issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices and standards that govern the pharmaceutical supply chain. Facilitates team level decision making and escalates key decisions to oversight committees.
  • Management Reporting - provides project updates, KPIs, risk analyses to management.
  • Knowledge Base - maintains an understanding of contemporary project management techniques and laws and regulations applicable to the pharmaceutical/biotechnology industry.
  • Proactivity - identifies any potential or actual delays and prepares appropriate prevention and mitigation plans.
  • Assist IT Leader in preparation for IT Steering Committee.
  • Manage IT Roadmap and each initiative to assure meeting timelines.

Competencies/Work Style:

  • Ability to build and manage relationships with business partners
  • Ability to prioritize tasks and work in a fast-paced environment
  • Excellent interpersonal, organizational and written as well as verbal communication skills
  • Ability to work within a team as well as independently in a matrix environment

Requirement/Qualifications:

  • Bachelor's or advanced degree in Business, Science, Engineering or related field-MBA preferred
  • Minimum of 8-10 years of biotech/pharmaceutical project and/or program management experience (preferably experience within Manufacturing or Supply Chain)
  • Broad knowledge across the spectrum of technical operations including quality and the entire supply chain: manufacturing, inventory management, logistics, distribution, transportation
  • Demonstrated effective cross-functional leadership as evidenced by line/project management or multi-disciplinary program management
  • Effectively drive and maximize resources through the application of project management best practices
  • Skilled in project management methods, tools and reporting and demonstrated effective program management methodologies
  • Exceptional critical thinking, judgment, and analytical skills to evaluate the importance and urgency of problems
  • Demonstrates the ability to work in a fluid, complex, dynamic environment; demonstrates interpersonal flexibility and resiliency to effectively lead through complicated programs and/or issues
  • Excellent written and verbal communication skills and ability to present to diverse audiences
  • Familiarity in Microsoft office - Excel, Word, PowerPoint, Project
  • Experience in GMP manufacturing and/or development environment preferred but not required

NOTE: This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.

NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.

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Senior Accountant
Wayne, PA

The Senior Accountant will be a key contributor to the financial close process and financial reporting for Synergy. He/she will be responsible for contributing to the production of accurate and timely reporting of financial results on a monthly / quarterly / annual basis. This role will also act as a liaison between Finance and the Business on travel and expense management.

Responsibilities:

60%:
Participate in the monthly and quarterly accounting processes, such as preparation of journal entries and supporting schedules. Responsibilities will include but are not limited to: cash application, vendor maintenance, fixed assets, , and process general ledger journal entries, including prepaid expenses and period end accruals. The Senior Accountant will also provide customer service to Technical Operations and Supply Chain in terms of accounting for and reconciliation of inventory.

15%:
Prepare and document balance sheet account reconciliations and financial statement analysis. In addition, provide ad-hoc reporting and analysis to support the financials and other projects.

15%:
Oversee the travel and expense processes at Synergy, including reviewing expenses reports, reconciling to credit card statements and releasing payment. Serve as partner to the business to resolve questions with Concur and ensure compliance with Travel Policy.

10%:
Monitor and evaluate the effectiveness of established internal controls to ensure compliance with Sarbanes-Oxley. This will include making recommendations for enhancements or modifications to existing processes and systems. Participate in all aspects of internal and external financial and internal control audits.

Competencies/Work Style:

  • Strong knowledge of GAAP and Sarbanes-Oxley compliance procedures and documentation.
  • Strong working knowledge and experience with SAP is required
  • Strong knowledge of MS Excel. Functional ability in Word and PowerPoint.
  • The ability to handle ambiguity and work effectively in a constantly changing environment is critical.
  • Excellent communication and interpersonal skills are needed. Must have the ability to interact with peers as well as management throughout the Company.
  • The successful candidate needs to be able to work in a fast paced environment, be creative, be energetic and be enthusiastic.
  • Strong analytical skills with attention to detail and ability to follow through on assigned projects

Requirement/Qualifications:

  • BS Degree in Accounting required
  • CPA with a background in public accounting, Big 4 is strongly preferred.
  • Prior experience as part of an accounting team within a pharmaceutical company is strongly preferred
  • Experience with Concur or comparable travel management software system is strongly preferred
  • A minimum of 5-7 years of related experience is required with at least 2 years in a corporate accounting environment

NOTE: This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.

NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.

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Quality Systems Manager
Wayne, PA

Responsible for maintaining and management within the Technical Operations Quality Systems and Metrics function for Synergy. Assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance.

Responsible for maintaining quality systems at Synergy including change control, deviation investigations, CAPA, document management, and training. Manage changes to electronic systems with GMP impact, including SAP and the electronic Quality Management System (eQMS) in accordance with 21CFR Part 11. System Administrator for the eQMS system.

Responsibilities:

  • Quality Management Systems:
    • Support and manage Synergy's internal quality management systems; e.g., systems for batch release and control, audits, policies and procedures, investigations and CAPAs, change controls, document management, and training management.
    • Primary system administrator for Synergy's eQMS system
    • Manage system change requests for GMP systems, including SAP and eQMS system.
    • Support continual process improvement of Synergy's quality systems and implementation of new electronic Quality System processes as needed.
  • Quality Metrics
    • Tracking and trending of Quality Metrics including but not limited metrics for procedures, change control, investigations, CAPAs, and complaints,
  • Training and Document Management:
    • Manage GMP document files, including SOPs, validation documentation, and manufacturing documentation
    • Maintain SOPs for Technical Operations and coordinate biennial reviews of SOPs
    • Manage training records for Technical Operations. Develop and maintain training curricula.
    • Create and manage training materials.
  • Develop and enhance Synergy policies and procedures related to quality management systems
  • Assist the Synergy Quality Assurance lead during regulatory inspections of GMP Contractors and Synergy facilities.
  • Assist in performing inspection readiness activities.
  • Review Quality Agreements.
  • Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry.
  • Participate on cross functional teams, as needed.
  • Provide periodic updates to Senior Director Quality Systems.
  • Participate in the selection and manage utilization of Synergy and contracted employees performing duties related to the quality systems function.
  • Perform additional activities related to the Quality function as needed.

Competencies:

  • In-depth knowledge of pharmaceutical industry legal and regulatory requirements.
  • High level of familiarity with practices needed to maintain compliance in the areas of GMP compliance, quality management systems, supplier management, annual product reviews, and training; and an ability to assess risk and develop solutions.
  • Ability to exercise strong business judgment.
  • Ability to work collaboratively across diverse functions, operate independently and build strong networks throughout the corporate organization.
  • Ability to build and manage relationships with business partners.
  • Ability to prioritize and align the organization with goals and objectives, and ensure rigor in operational excellence.
  • Ability to lead high performing teams.
  • Excellent interpersonal, communication, training and presentation skills.
  • Strong investigation and monitoring skills.
  • Attention to detail and implementation good documentation and processes are essential.

Requirement/Qualifications:

  • Bachelor's Degree in a life science-related discipline (advanced degree preferred).
  • Minimum of 5 years of GMP quality experience, including GMP compliance, quality management systems, computer system validation, supplier management, document control, and training.
  • Prior interaction with senior-level management.
  • Prior experience in the following areas required:
    • Computer System Validation
    • Training management
    • Document management
    • Change Control
    • Deviation investigations
    • CAPA
    • Quality Metrics
  • Experience with the following a plus
    • SAP
    • SharePoint
    • 123Compliance
    • Auditing
    • Learning management systems
    • Document Management Systems
    • System Administration of a 21CFR Part 11 Compliant system
    • Operational Excellence, including and Lean and Six Sigma methodologies
  • Experience in demonstrating strong interpersonal skills, a flexible, collaborative and team-oriented approach to problem solving, and an ability to work in a fast-paced, rapidly changing environment.

Significant Contacts/Relationships:

  • Executive leadership
  • Regulatory Affairs
  • Clinical Quality
  • Quality Operations
  • Manufacturing Sciences & Technology
  • Information Technology
  • Commercial
  • Contract Manufacturing and Laboratory organizations
  • System Vendors
  • Corporate Compliance

NOTE: This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time.

NO PHONE CALLS PLEASE AND NO AGENCIES OR RECRUITERS.

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