Bioniche Pharma (a Mylan Company) based in Kilroe, Inverin, Co. Galway (25Km west of Galway City) is a global manufacturer of injectable pharmaceutical products serving a variety of niche markets, with expertise in injectable hyaluronic acid products for use in orthopedics, rheumatology, urology and dermatology.

Mylan is one of the world’s leading generics and specialty pharmaceutical companies, providing products to customers in more than 150 countries and territories. The company ranks among the top five generics companies in several markets around the world and is the largest U.S. based generics manufacturer in the world employing over 18,000 people worldwide.

A vacancy has arisen within the Research & Development (R&D) Department of Bioniche Pharma based in Inverin, Co. Galway for the position of Formulation Development Manager.

The successful candidate will be responsible for the development of sterile injectable products, scale up with transfer to production, support regulatory submissions and provide leadership at project and team level and will report directly to the Head of Formulation Development.

ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must satisfactorily perform each essential duty.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

1. Responsible for the delivery of a diverse range of injectable drug products for registrations and successful launches.
2. Responsible for managing multiple challenging deliverables to agreed deadlines.
3. Managing and development of direct reports whose activities include;
• Input for selection of API supplier;
• Development of Injectables, suspensions and Lyophiles;
• Nomination of Drug product formulation, packaging and manufacturing process;
• Setup and operation of pilot scale processes for product development;
• Scale up injectable manufacturing processes and technical transfer to production site for registration and launch;
• Preparation of batch documentation for GMP sterile manufacture;
• Technical reports writing for global regulatory submissions.
4. Provide technical leadership on cross functional complex product teams.
5. Develop efficient processes and procedures for product development to ensure quality and attain best balance of time/cost.
6. Construct project plans and budgets for development activities and deliver to agreed criteria (Cost, Quality and time).
7. Resource planning and budgeting for group.
8. Work cross functionally with counterparts and management in other departments (Analytical, Quality, manufacturing and Regulatory).
9. Provide clear communications to department and site management.
10. Provide technical input to production site.
11. Ensuring safe working practices in compliance with company policies.
12. Support technical evaluations of other product business opportunities.
13. Perform other duties as assigned.

QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE 
Development of injectable solutions with technical expertise in the following areas;
- Ability to lead and manage members of a formulation & process development team. 
- Experience with Sterile product development and scale up for both injectables and lyophile product development.
- Understanding of solution chemistry, degradation pathways and how to select a formulation/process to optimise shelf life.
- Process development and defining unit operations/process parameters for sterile liquid manufacture (e.g. compounding, filling through to sterilization).
- Microbiological fundamentals and knowledge of unit operations to secure sterility (e.g. defining F0 cycle, Autoclaving, aseptic techniques and other terminal sterilization processes).
- Packaging selection, leachables & extractable and compatibility.
- Familiar with QbD, GMP and Quality requirements for pharmaceutical product development.
- Project management, resource planning and budgeting.

SKILLS AND ABILITIES
In addition to technical skills;
- Track record of showing how results were delivered through management/leadership of others.
- Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
- Development and training of team members.
- Excellent communication skills (verbal and written).
- Microsoft project planning (or similar software).
- Proficient computer skills (Excel, word, powerpoint, databases).

SUPERVISION
The position will involve direct supervision of at least 5 or more employees.  Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION/EXPERIENCE
Minimum of a scientific Bachelor's degree (Physics/Chemistry/pharmaceutical sciences) and 10 years of relevant experience or PhD with a minimum of seven years relevant industrial experience.  However, a combination of experience and/or education will be taken into consideration. 

LICENSES/CERTIFICATIONS
None.

LANGUAGE SKILLS
Ability to read and interpret comprehensive and intricate research documents.  Ability to write scientific reports and technical correspondence.  Ability to work with executives and communicate abstract concepts.   Ability to present to a high level of the organization and groups outside of the organization.

MATHEMATICAL SKILLS
To level reached  in scientific degree (e.g. Statistical knowledge for data interpretation and planning experiments).
 
REASONING ABILITY
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis.  Ability to draw inferences and use deductive reasoning with no prescribed procedures to solve complex problems.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.
Typically sitting at a desk or table.  Intermittently sitting, standing, walking or stooping.  Require use of hands and use of arms. Medium lifting requirements. 

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Predominantly laboratory and office environment with some activity in production plant during technical transfer.

Bioniche Pharma can offer the successful candidate challenging experiences and unlimited opportunities for personal growth and professional advancement.

Bioniche Pharma is an equal opportunities employer

Bioniche Pharma does not require Agency Assistance with this role - thank you.