Maximizing talent to make a difference

SCIENTIST/PROCESS ENGINEER – MANUFACTURING SCIENCES AND TECHNOLOGY (MSAT) AND TECH TRANSFER

The Scientist/Process Engineer for MSAT and Tech Transfer will support late stage and commercial phase biologics and small molecules including technical and scientific aspects of drug substance and drug product manufacturing. Responsibilities include routine manufacturing support (batch record review and contract manufacturer oversight), providing technical expertise and scientific support for manufacturing changes, deviations, CAPA, and root cause analysis. The Scientist/Process Engineer will also develop and execute process control strategies for continuous process verification (CPV), design and execute process capability assessments; participate in process and technology transfer; act as person-in-plant (PIP) and as a Medexus representative at contract manufacturers inside and outside the US (when travel is deemed safe). The Scientist/Process Engineer – MSAT and Tech Transfer will report to the Director, Program Management and Operations.

The successful candidate will have a Bachelor’s and/or a graduate degree in Biochemistry, Biology, Chemical Engineering, Bioengineering, Pharmaceutical Technology or related discipline.  Six or more years in Biotech/Pharma with expertise in biologics manufacturing including cell culture, purification, formulation and drug product fill is necessary for this role. A minimum of three years’ experience in a cGMP manufacturing environment on the biologics manufacturing floor and/or as a PIP is required. Strong working knowledge of FDA, EMA, and ICH guidelines as applied to late stage and commercial phase biologics and experience with regulatory agency inspections is preferred.

MANAGER/SENIOR MANAGER SALES OPERATIONS

The Manager/Senior Manager, Sales Operations will report to the Director, Commercial Operations & Business Insights and will direct all internal sales operations that support the Field Sales Organization in all aspects of administration business analysis and sales force optimization in a way that helps meet company earnings target.  Responsibilities include leading the customers targeting process and territory alignment and targeting process across the Medexus portfolio of brands; forecasting and monitoring the operating budget for the sales organization; sales data reporting; CRM oversight; and developing and administering the Sales Incentive Compensation Program (SICP).

The successful candidate will have a bachelor’s degree in Business Administration, Statistics or Mathematics; managerial experience in the pharmaceutical industry and a minimum of 3 years of experience in the pharmaceutical industry in the areas of Sales Operations, Analytics, Data Management and Sales reporting.  Will demonstrate an in-depth knowledge of sales and marketing operations, policies and procedures; will have an in-depth understanding of the regulatory guidelines and requirements as they apply to field sales; will demonstrate effective knowledge of budgeting process, accounting principles, and effective analytical forecasting and problem-solving skills; will demonstrate enhanced computer and database skills and advanced business and management skills; and will have the ability to manage and prioritize multiple projects simultaneously.

QUALITY CONTROL MANAGER

The Quality Control Manager will oversee all analytical work occurring at contract organizations including analytical development, in-process analysis, bioassays, and release testing for drug substance and drug product.  They will ensure that analytical methods are developed and qualified/validated per cGMP and that all QC activities are conducted in accordance with global regulatory requirements to ensure ongoing supply of product to meet clinical and commercial demand.  The QC Manager will lead comparability, stability and method performance trending programs.

The qualified candidate will have a PhD in biology, biochemistry, biopharmaceutical sciences or other biological science related discipline and 7+ years progressive cGMP quality, testing, scientific, and/or manufacturing experience in pharmaceuticals including biologics. Expertise in chemical, protein and bioassay including experience on the bench is required.  Experience with recombinant form of human factor IX or similar commercial biologics is desired.

RARE DISEASE & IMMUNOLOGY SPECIALIST

• Various Open US Territories

To achieve our goal of helping patients live better lives, the Rare Disease & Immunology Specialist will work to bring our novel therapies for the treatment of autoimmune and blood disorder diseases to the market.

Utilizing a blend of business acumen, professional performance skills and integrity within the marketplace, the Rare Disease & Immunology Specialist will drive business results. The successful candidate will be responsible for the promotion, sales and support of Medexus Pharma products.

Qualifications include a bachelor’s degree, with three plus years of pharmaceutical / biopharmaceutical or specialty pharmacy experience, hemophilia experience is preferred. You will be able to demonstrate a proven track record of top sales performance and achievements. Additional requirements include a strong work ethic, with the ability to collaborate within a team environment, along with a pro-active, can-do approach, and excellent interpersonal and relationship building skills. Overnight travel will be required. The successful candidate will live in the greater metropolitan area of the territory for which they are applying.