Position Title:    VP Business Development
Department:      Product Development Services (PDS), North America

Responsibilities: The VP Business Development, PDS North America will be responsible for generating North American revenues for NextPharma’s PDS Business Unit. Product Development Services include formulation development, clinical trials manufacturing Preclinical - Phase II), clinical trials packaging, and associated analytical services across a wide range of product forms.

Requirements:

1. BA/BS is required; degree in the Biological Sciences or Chemistry is preferred.
2. Ten (10) years of experience in pharmaceutical or medical device industry is required.
3. Five (5) years of experience in a sales or business development position in the pharmaceutical or medical device industry is required.
4. Three (3) years experience in pharmaceutical or medical device contract manufacturing services is required.
5. Strong organizational, communication, people skills, verbal and written skills is required.  
6. Three (3) years of supervisorial experience is required. 
7. Excellent documentation and record keeping skills are essential. 
8. Person must be analytical, detailed oriented, able to keep to a timeline, self-motivated, and computer literate (Word and Excel).
9. Must be a team player, customer service oriented, and able to travel and work flexible hours.

Duties:  The key duties of the VP Business Development PDS North America are to:

• Establish, train, maintain, coach and lead North American business development team;
• Develop strong relationships with NextPharma PDS and manufacturing operating units in Europe and the US;
• Agree and achieve realistic North American revenue targets;
• Build a network of key decision makers for PDS services within the North American pharmaceutical, specialty pharmaceutical and biotechnology industries;
• Manage strategic existing and new commercial relationships;
• Provide competitive intelligence and review marketing materials;
• Organize and attend major networking conferences;
• Provide significant input into PDS’s annual planning process and on-going PDS strategy, including providing leadership and guidance as the business unit enters new service areas or acquires additional companies.

Posted

March 20 , 2008

Position Title:  Director of Operations
Department:    Manufacturing

Responsibilities: The Director of Operations is responsible for the management of the company’s operational groups and the development of business strategy.  This position is manages department heads in Aseptic and Non-aseptic manufacturing, Supply Chain and Facilities and requires a broad knowledge base of these functional areas.  The Director must be able to interpret the customers’ needs and adapt their requirements to the capabilities of Bioserv, including applicable manufacturing operations, manpower, equipment needs, quality control systems, documentation, and regulatory requirements for medical devices and pharmaceuticals, and be able to oversee the transition of those needs to manufacturing floor.  This position reports to the Vice President of Operations.

Requirements:

1. BA/BS degree in the Biological Sciences or Chemistry is required.
2. Knowledgeable in all aspects of the device and pharmaceutical businesses.
3. Minimum of 5 years supervisory experience in device and/or pharmaceutical business at senior management positions. 
4. Must possess leadership and management skills.  Must possess technical knowledge and skill. 
5. Thorough knowledge of Total Quality System including QSR, cGMP and ISO regulations is required.
6. Strong organization, communication, verbal and written skills required.  
7. Person must be analytical, detailed oriented, able to keep to a timeline, self-motivated, and computer literate (Word and Excel).
8. Must be a team player, customer service oriented, willing to learn, and able to work flexible hours.

Posted

March 20 , 2008

Position Title:    Director, Formulation Development and Analytical Services
Department:      Formulation Development and Analytical Services

Responsibilities: The Director of Formulation Development and Analytical Services will be responsible for setting up a new department focused on Formulation Development and Analytical Services. This will include formulation development, lyophilization cycle development, and analytical testing across a wide range of product forms for pharmaceutical, specialty pharmaceutical, biotechnology and medical device industries.

Requirements:

1. MS or PhD. in the Biological Sciences, Pharmaceutical Sciences, Chemistry or similar discipline is required.
2. Ten (10) years of experience in pharmaceutical or medical device industry is required.
3. Five (5) years of experience in formulation development or analytical position in the pharmaceutical or medical device industry is required.
4. Publication(s) regarding formulation development or analytical testing in scientific peer reviewed journals is preferred.
5. Three (3) years experience in pharmaceutical or medical device contract manufacturing services is required.
6. Strong organizational, communication, people skills, verbal and written skills is required.  
7. Three (3) years of supervisorial experience is required. 
8. Excellent documentation and record keeping skills are essential. 
9. Person must be analytical, detailed oriented, able to keep to a timeline, self-motivated, and computer literate (Word and Excel).
10. Must be a team player, customer service oriented, and able to travel and work flexible hours.

Duties:  The key duties of the Director, Formulation Development and Analytical Services are to:

• Set-up new Formulation Development and Analytical Testing Department for Bioserv within the timeline and budget.
• Establish, train, maintain, coach and lead formulation development and analytical team;
• Develop strong relationships with NextPharma PDS and manufacturing operating units in Europe and the US;
• Develop a core competency at Bioserv in formulation development and analytical testing for the pharmaceutical, specialty pharmaceutical, medical device and biotechnology industries;
• Provide technical support to Manufacturing and Quality Assurance Departments
• Manage formulation development and analytical services projects;
• Provide competitive intelligence and review marketing materials related to area;
• Attend major networking conferences;
• Provide input into Bioserv’s annual planning process and on-going strategy.

Posted

March 20 , 2008

Position Title:  Project Coordinator (I/II)
Department:    Manufacturing

Responsibilities:

The Project Coordinator is responsible for coordinating and running processes associated with the manufacture of the customer’s product in the pharmaceutical group, and will be the company’s primary liaison with specific customers.  This includes communication with the customer, ensuring inventory is available to begin the process, and coordinating the scheduling of the job including the needs of personnel, equipment and space. The Project Coordinator is directly involved in the set-up, formulation and aseptic filling and lyophilization of buffers and solutions, and the timely completion of all associated documentation throughout the entire process. They are to ensure that personnel follow all regulations and written procedures applicable to the job.  Project Coordinators will also write procedures, perform validations, and investigate failures as necessary.   The ideal candidate should be able to work with minimal instructions, and should be able to provide some direction to area technicians. 

Requirements:

1. Bachelor’s Degree in the biology or chemistry is preferred. Minimum of 3-4 years of college coursework in the sciences, or equivalent work experience is required.
2. Aseptic manufacturing experience is strongly preferred.
3. Good documentation, strong organizational and record keeping skills are essential. 
4. Excellent verbal and written communication skills are required.
5. Must be a team player, customer service oriented, willing to learn, and able to work flexible hours.

Posted

March 20 , 2008

Position Title:  Pharmaceutical Technician (I/II)
Department:    Manufacturing

Responsibilities:

The Manufacturing Technician is responsible for supporting and performing routine procedures associated with the manufacture of the customer’s product in the Pharmaceutical group.  They will assist Project Coordinators and the Technician Lead in the manufacture of product as assigned by management in compliance with applicable regulations (e.g. ISO’s, cGMP’s, QSR’s).  The technicians’ primary function is to perform a variety of labeling, packaging operations, sterilize containers, closures, and components, perform environmental monitoring in the cleanrooms, and assist in a variety of product formulations and aseptic filling operations.

Requirements:

1. High school diploma or equivalent is required. Coursework in the sciences is helpful.
2. Some experience within a Quality regulated manufacturing laboratory is desirable.  Cleanroom experience is strongly preferred.
3. Good documentation and record keeping skills are essential.
4. Must be a team player, customer service oriented, willing to learn, and able to work flexible hours.

Posted

March 20 , 2008

Position Title:  Production Chemist (I/II)
Department:    Manufacturing

Responsibilities:

The Production Chemist is responsible for coordinating and running processes associated with the manufacture of the customer’s product. This includes communication with the customer and production control to ensure that inventory is available to begin the process, and coordinating the scheduling of the job including the needs of personnel, equipment and space with the area supervisor. The Production Chemist is directly involved in the set-up, formulation of buffers and solutions, and the timely completion of all associated documentation throughout the entire process. Production Chemists will also assist with writing procedures, assist with validations, and investigate product failures as necessary.   The ideal candidate should be able to think and work quickly with minimal instructions. 

Requirements:

1. Bachelor’s Degree in the biology or chemistry is preferred. Minimum of 3-4 years of college coursework in the sciences, or equivalent work experience is required.
2. Good documentation, strong organizational and record keeping skills are essential. 
3. Excellent verbal and written communication skills are required.
4. Must be a team player, customer service oriented, willing to learn, and able to work flexible hours.

Posted

March 20 , 2008

Position Title:  Production Control Analyst/Specialist
Department:    Manufacturing

Responsibilities:

The Production Control Analyst/Specialists’ main responsibility is to schedule and prepare for the manufacture of new and current customer product lines.  The Production Analyst/Specialist must be able to interpret the customers’ needs and adapt their manufacturing requirements to the capabilities of Bioserv, which requires a general laboratory manufacturing knowledge base.  The Production Control Analyst/Specialist must have a very good sense of material handling, inventory control, applicable manufacturing operations, equipment needs, quality control systems, documentation, and regulatory requirements in order to translate these requirements into batch history records and raw material receiving specifications.  The Production Control Analyst works with the area manager, Materials Management and Business Development to maintain and update the Master Production schedule for the appropriate manufacturing group. 

Requirements:

1. Bachelor’s Degree in the biology or chemistry is preferred.  Minimum of 2-3 years of work experience is required in a quality regulated bio-pharmaceutical or medical device manufacturing company is strongly preferred.
2. Good documentation, strong organizational and record keeping skills are essential. 
3. Excellent verbal and written communication skills are required.  Strong technical writing skills are desirable.  Ability to word process is essential. 
4. Must be a team player, customer service oriented, willing to learn, and able to work flexible hours.

Posted

March 20 , 2008