Company Operating Name: Gilead Alberta ULC.
Company Background: Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff of over 6,500 people is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in 16 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Location Background: Gilead's manufacturing facility in Edmonton, Alberta, is responsible for the development and manufacturing of investigational drugs. We supply active pharmaceutical ingredients for clinical research programs and contribute supplies for new product launches.
We offer you the opportunity to work within a culture of highly motivated, talented individuals who are dedicated to the company's mission. Each job provides wide-ranging responsibilities due to our cross-functional organizational structure and leadership style, which ensures that everyone is engaged, committed and accountable.
We are looking for individuals from diverse backgrounds who want to work together and support each other to help make a real difference in the lives of patients - people who thrive on performing well within a challenging and fast-paced environment, living our core values of Integrity (always doing the right thing), Teamwork (collaborating in good faith), Excellence (working at a high level of commitment and capability) and Accountability (taking personal responsibility).
Business & Mailing Address: 1021 Hayter Road, Edmonton, Alberta, T6S-1A1, Canada.
Contact Information: 780-701-6400 (phone); 780-472-8189 (facsimile).
Position Description: Gilead Alberta ULC in Edmonton, Alberta Canada is seeking an experienced and knowledgeable individual to assume the position of Sr. Research Scientist II in Gilead’s Process Development department. Position will remain open until a suitable candidate is found.
Position Type: Permanent, Full-time
Specific Responsibilities: This role will manage the lab operations and provide guidance to other research scientists and associates working in the lab. He/She will assist in departmental management of various functional activities, and participate in the recruitment, selection, management, development and evaluation of staff. This position is responsible for the supervision of project team and research assignments; ensures that quality, safety and environmental standards are maintained, and ensures that product delivery deadlines are met. The selected candidate will collaborate with contacts across areas and levels to accomplish project goals. Serves as a scientific representative both within and outside the organization.
- Responsible for developing chemical processes for the manufacturing of drug substances.
- Plans, designs, implements and analyses laboratory experimentation to advance scientific knowledge of drug substances or drug products.
- Directs members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
- Develops and executes project strategies/plans and coordinates project teams to ensure deadlines are met.
- Acts as Process Chemistry Lead for multiple projects on site and on PDM sub-team levels as required.
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
- In cooperation with the Analytical Chemistry department, develops appropriate tests and specifications for the control of processes and product quality during manufacturing.
- Provides supervision and technical support for manufacturing processes in Laboratory Manufacturing and Manufacturing Plant.
- Reviews batch records and necessary reports (i.e. DV, Quality Investigations etc.) in a timely manner.
- Prepares Development reports, Validation Plans and Protocols, and Validation Reports, and directs validation activities for the assigned projects.
- Ensures that all operations in the laboratory are carried out in an efficient manner and according to cGMP.
Safety and Environment:
- Ensures that the work environment is kept clean, tidy and that all operations are carried out in a safe manner.
- Follows all procedures as outlined in the Company Environmental, Health and Safety Policies.
- Attends departmental Environmental, Health and Safety and Quality (EHSQ) meetings regularly & completes all required Safety trainings.
- Attends and obtains passing scores in all required GMP training sessions.
- Ensures that he/she and any assigned staff have been trained on appropriate SOPs and/or hands on training forms before performing a task.
- Ensures that SOPs are followed as written and required information is recorded properly.
Essential Duties and Job Functions:
- Develop chemical processes for manufacturing drug substances
- May lead projects related to delivery of Active Pharmaceutical Ingredient (API) or Drug Substance (Investigational New Drug (IND) exemption) to support toxicology as well as first-in-human Phase I clinical studies
- Help advance the development of economical and state-of-the-art techniques to isolate, characterize, purify, and mass-produce substances
- Plan, design, implement, and analyze laboratory experiments to advance scientific knowledge of drug substances or drug products
- Provide direction to members of project teams on initiation and execution of laboratory experimentation, while considering economic, regulatory, and safety factors
- Use ingenuity and creativity when working on complex problems, where analysis of a situation or data requires evaluation of intangible variables
- Provide major contributions to scientific literature and conferences through publication and presentation of research results
- May act as a spokesperson, internal consultant, and/or advisor for top management on corporate research and development direction
- Maintain in-depth knowledge of principles and theories and apply that knowledge to support company interests
- Demonstrate technical proficiency, employ scientific creativity, think independently, and collaborate with others when suggesting experimental design and research strategies
- Work independently, creatively, and think critically to determine appropriate resources for resolution of problems
Knowledge, Experience and Skills:
- 12+ years of industrial experience and PhD in Chemistry.
- BS or MS degree with extensive industry experience.
Compensation: $119,925.00 - 203,875.00 Annual Salary; Bonus; Comprehensive Benefits Package Included; RRSP Benefits; Additional Benefits. Relocation Package Provided.