Position Summary:

Directly supervises a small team of scientists that are typically assigned to a specific functional area. Acts as lead on multiple programs. Investigates, creates, and validates new scientific methodologies on a complex scope of projects. Works on technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations. Leads technical discussions with clients with a high level of technical proficiency. Evaluates and oversees the design of processes and supports problem solving. Makes decisions that require developing new options to solve complex problems. Determines methods and procedures on new assignments and may coordinate activities of other employees.

Key Responsibilities:

• Provides leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best. Leads design of experimental plans based on the defined deliverables.
• Conducts complex analyses to support process development. Works with Process Development and Manufacture groups to trouble-shoot process challenges.
• Records results in notebook accurately, clearly, and regularly, and reviews documentation by others.
• Prepares protocols, reports, and test methods and writes SOPs.
• Maintains and ensures safe laboratory environment and work practices.
• Executes appropriately record and evaluate experimental data, including the writing and revising of process development reports and technology transfer protocols as needed.
• Remains current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences.
• Plans project scope, timing and resource requirements.
• Acts as functional group technical lead on multiple programs, with responsibility for running those programs within own functional group.
• Collaborates with Program Management and technical leads from other cross functional areas to ensure clear expectations and successful deliverables.
• Serves as primary contact with clients and provides regular communication of data and status. Leads relevant program team meetings.
• Trains and mentors less experienced Scientists and provides technical leadership.
• Supervises Scientists at multiple levels.

Frequent Contacts:

Internal

• Department leaders and individual contributors
• Leadership team
• Project leads

External

• Customers
• Vendors
• Other business units

Minimum Requirements/Qualifications:

• Bachelor's degree or Master's degree or PhD in biology, chemistry, biochemistry, chemical engineering, or a related field.
• With Bachelor’s degree, minimum of 8 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory and that includes relevant industry and discipline experience.
• With Master’s degree, 6 years of experience related to pharmaceutical manufacturing, process, development or academic laboratory and that includes at least 2 years of relevant industry discipline experience.
• With PhD, significant practical scientific application directly related to job responsibilities; related industry and discipline experience preferred.

Other Job Requirements:

• Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
• Advanced and deep knowledge of varied aspects or a specialized aspect of discipline and working knowledge of principles and concepts in other relevant disciplines.
• Strong knowledge of general cGLP procedures and those specific to discipline.
• Strong knowledge of GMP/ GLP regulations in cGMP/ cGLP manufacturing environment.
• Demonstrated leadership skills.
• Excellent problem solving and critical thinking skills.
• Excellent writing, communication and presentation skills.
• Strong MS Excel, PowerPoint and Word skills. Microsoft Project skills preferred.
• Excellent organization and planning skills.
• Strong attention to detail and ability to adhere to standards procedures.
• Ability to drive functional, technical and operational excellence.
• Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
• Ability to design complex studies based on the deliverables.
• Ability to analyze and summarize complex scientific data.
• Ability to author reports, procedures, and other documents.
• Ability to function in a rapidly changing environment.
• Strong attention to detail and ability to adhere to standards procedures.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to make and communicate complex decisions.
• Ability to apply complex mathematical concepts to physical problems in areas.
• Ability to apply rigorous attention to detail when executing experimental protocols.
• Ability to perform all process steps and to guide manufacturing on the operation of all process steps.
• Ability to speak effectively before groups of customers and employees.
• Ability to apply complex mathematical concepts to physical problems in areas such as heat and mass transport.