X-GEN Pharmaceuticals, Inc. continues to experience steady growth and this results in rewarding employment opportunities for candidates with the right skills. X-GEN Offers Pay and Benefits that Include: Vacation, Simple IRA, Professional Growth, Advancement and Health Insurance.
Title: QA Manager, External Manufacturing
Reports to: Director of Quality
This position is responsible for providing day to day quality input and oversight for successful life cycle development and commercialization of generic pharmaceuticals at external manufacturing partners globally and ensuring that the operational business is in compliance with cGMP, the Quality Agreement, regulatory requirements and X-GEN’s Quality Management System. The Manager, External Manufacturing, Quality Assurance, will act as the lead quality point of contact for assigned Projects.
- Supports X-GEN’s Mission and Vision statement by adhering to the Code Of Corporate Values and conforming to established performance expectations.
- Independently manage and provide quality oversite as well as lead daily quality related interaction and commercial production execution and/or product transfers with third parties and cross functional teams to assure:
- Quality and compliance related matters meet appropriate GMP and regulatory requirements
- Product is safe, pure and effective for distribution by direct review and inspection of the finished goods and documentation.
- All documentation for release is present, accurate and within established ranges and specifications
- Approval or rejection of product based on conformance to specifications, current Good Manufacturing Practices (cGMP’s) requirements and /or contractual agreements.
- Representation of the department and X-Gen on cross-functional project teams and external business partner meetings
- Compliance with cGMP’s, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third party contract manufacturers and external partners
- High performance of third party contract manufacturers by implementation of quality metrics and scorecard.
- Assures timely launch of new products by:
- Serving as the Quality lead for technical transfer activities at external manufacturing partners
- Reviewing ANDA filings for identification of deficiencies and compliance to the requirements
- Supporting manufacturing activities related to regulatory filings (i.e. on-site presence for engineering, validation, registration batch manufacturing, timely review and approval of documents, etc.)
- Participation in and advisement of responses related to filing deficiencies.
- Supports X-GEN’s Operations related to commercial product distribution by:
- Approving and releasing commercial product
- Leading investigations associated with product non-conformances and deficiencies identified during inspections, manufacturing, and product complaints
- Certifying that all incidents, complaints, and investigations are properly documented
- Verifying corrective actions for prevention of reoccurrence are completed in a timely manner and are consistent with the stated corrective action
- Investigating and determining the need for field alerts or recalls of company products manufactured by third party contract manufacturers
- Reviewing and approving quality records/documentation from third parties, including but not limited to product and process change controls (e.g., master batch records, API, raw material, product specifications, analytical methods), stability and validation protocols/reports, quality incidents and investigation reports, quality agreements and technical transfer documentation
- Perform on-site visits during manufacturing/packaging of X-GEN products and attend quality business reviews at external manufacturing partners to assess compliance with cGMPs and X-GEN’s requirements
- Participating in Agency and X-GEN inspections of external manufacturing partners to ensure successful inspection outcomes and maintain a constant state of inspection readiness at these sites
- Performing quality risk assessments and driving risk reduction improvement plans and remediation where necessary
- Driving quality compliance and performance metrics with external manufacturing partners and reporting metrics on a routine basis
- Compliance with cGMP’s, regulatory, compliance requirements, and contractual agreements by developing and revising necessary company policies and procedures to support management of third party contract manufacturers and external
- Performs other related duties as assigned or directed.
Bachelor’s Degree in science-Related (Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering) 5-8 years of work experience in Quality Assurance within the pharmaceutical industry or 3-5 years of experience working with pharmaceutical Contract Manufacturing Organizations (CMOs) and business
Training (licenses, programs, or certificates):
- ASQ Certified Auditor (desirable, not required)
- Quality Assurance and Quality Control; cGMP; Contract Manufacturing (CMO); domestic and foreign regulations governing GMP plant operations and Relationship Management. Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines
- Proficient in reading, writing, grammar, and mathematics skills, interpersonal relations, communications skills, computer skills including Microsoft Office, Go to Meeting.
Travel: 50% domestic and international travel required
Title: Manager of Inside Sales
Reports to: Director of Sales and Trade Relations
Overseeing outbound sales calls to targeted customer classes with the objective of acquiring new accounts, growing existing accounts, retaining existing accounts and gathering intel about accounts. Hiring, training and evaluating inside sales staff. Monitoring inside sales staff performance in order to ensure that goals are met. Communicating with cross-functional teams to develop procedures for increasing sales, reaching additional markets and promoting business. Managing advertising or inside sales team, setting campaign objectives, evaluating performance, and facilitating training. Coordinating product research and development and evaluation of campaign results. Oversee all call campaigns, planning strategies, preparing budgets, and reviewing promotional materials. Tracking and analyzing metrics and providing reports on performance. Developing call scripts and formulas to improve results. Resolving customer problems, complaints and inquiries.
- Supports X-GEN’s Mission and Vision statement by adhering to the Code Of Corporate Values and
conforming to established performance expectations.
- Manages overall activity of the department and directly supervises assigned personnel as follows:
- Assists in the selection of new personnel as appropriate;
- Makes provisions for the proper orientation and training of new personnel;
- Reviews employee performance on a regularly scheduled basis;
- Develops recommendations for employee career planning and development and oversees process for individual skills assessment and continuing education plans;
- Coaches and directs personnel to ensure compliance with departmental goals, objectives and budgets;
- Conducts regular meetings and provides guidance and direction to personnel;
- Reviews employee’s time records, makes any necessary corrections, obtains appropriate signatures and submits for payroll processing;
- Organizes, schedules, prioritizes and distributes workload among assigned personnel;
- Keeps personnel informed of pertinent policies and procedures affecting the department and/or their jobs; Creates an atmosphere in which upward communication from employees is encouraged;
- Administers personnel policies and procedures as established by company policy;
- Manages cost center expenses as follows:
- Constructs budget within prescribed guidelines;
- Manages expenses to stay within budget; requests and approves payments depending on level of authority;
- Reviews expenses on a regular basis to ensure proper recording of account expenses;
- Explains variances, exceptions and other impacts that occur between budget and actual expenses;
- Administers personnel policies and procedures as established by company
- Track and analyze metrics, and provide reports on performance.
- Develop call scripts and formulas to improve results.
- Train and manage Inside-sales team with the aim to improve performance over time.
- Assist in creating incentive program.
- Campaign Management with pre and post analytics.
- Increase Quantity & Quality of calls.
- Performs other related duties as assigned or directed
- Campaign Planning
- Call Center Support
- Product Marketing
- Lead Generation
- Outbound Calling
- Proficient reading, writing, grammar, and mathematics skills;
- Proficient interpersonal relations and communication skills;
- Proficient computer skills: including Microsoft Office, Go To Meeting, etc.
- Travel: Minimal
- Bachelor’s degree in a business related discipline
- A minimum of 5 years experience
Title: Manager of Project Management
Reports to: VP of Business Strategies
This position manages X-GEN’s new project activities from project acceptance through project completion. The position leads project initiatives, develops and implements improvements to facilitate project efficiency and mitigate risks to attain desired results.
- Supervises the department in accordance with X-GEN’s policies and applicable
- Responsibilities include training related to planning, assigning and directing work; appraising performance; disciplining employees; addressing complaints and resolving problems.
- Work with cross functional team to evaluate new product opportunities;
- Evaluate and prepare product information reports and present product analysis to senior management for evaluations and final decisions;
- Ensure review and proposal of draft contractual agreements with API suppliers, and contract manufacturers. Make recommended changes prior to sending to senior management and legal for final evaluation;
- Responsible for sourcing Active Pharmaceutical Ingredients (API), identifying Contract Manufacturers, Contract Laboratories for development and product testing;
- Lead and manage Project Management personnel;
- Lead and manage projects from project acceptance through product launch or designated project
- Act as liaison between X-GEN senior management, staff, trading partners, manufacturing partners, suppliers and regulatory agencies to ensure compliance with project plan and federal regulations;
- Other duties as required.
- Strong computer skills (MS Project, Office Suite, Outlook, e).
- Must be highly organized and possess strong communication and facilitation skills
- Traveling required a minimum of 5 days per month
- A thorough understanding of the ANDA process, eCTD submissions, SPL labeling, cGMPs and in-house SOPs.
- Bachelor’s Degree plus a minimum of 10 years of business experience
- Five (5) years of experience in project Certified Project Manager (CPM) certification a plus but not a necessity.
Application Procedure Candidates:
For consideration, please submit an electronic cover letter and resume, along with salary requirement, on our website. (email@example.com) Resumes and cover letters will be accepted until the position is filled.
Thank you for your interest in the Project Manager position at X-Gen Pharmaceuticals.
X-GEN Pharmaceuticals is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA.Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet
If you would like to submit a resume for future consideration, please use the form below.
300 Daniel Zenker Dr
Horseheads, NY 14845
+1 (866) 390-4411