Work Schedule
First Shift (Days)

Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As a Manufacturing Scientist II, you will lead and/or implement activities for the development of new and established manufacturing processes of solids, liquids, and semi-solid dosage forms. Project management skills will be applied to implement the scaling up manufacturing processes, supporting new product validations and post approval qualifications activities. This will require the writing, approval, and routing documents within a manufacturing setting.

You will be the primary technical representative on client projects and will work closely work with internal and external project teams of analytical, quality, and project management representatives. Supporting process development and commercial activities will be required. Leads technical/scientific project activities and discussions to lead strategies and technical solutions that meet client needs and expectations.

• Time bound outlines to complete activities for the validation of new products and manufacturing processes of solids, liquids, and semi-solid dosage forms.
• Leverage current leadership skills to provide support, mentoring and guidance to internal team members and clients for product and process development activities performed in commercial manufacturing areas.
• Lead client calls as primary technical representative and provide scientific justification for the project decisions and recommendations.
• Own the review and planning of all technical aspects of the project which includes prioritization of multiple projects or tasks to meet the appropriate timeline achievements.
• Integrate risk-based approach during the scale up and commercialization of processes and develop appropriate mitigation strategies.
• Draft quality batch production records, protocols, and reports to support product development, validation activities, and routine commercial batches.
• Support routine manufacturing operations in order to assure timely release of products with appropriate quality attributes and providing stewardship for commercial products of responsibility.
• Lead with project leadership skill required for daily meetings
• Work independently within the Technical Services Department and work as team member within the department
• Managing work independently with standard work planning and abilities to meet timelines established for projects.
• Proficiencies of Leadership, Trust, Diversity and Focused behaviors are required for the position.
• Quality attitude to be exemplified daily with standard work.
• Outstanding team dynamics and idea generation is promoted.

• Minimum of one (1) to three (3) years of experience in a manufacturing environment. Experience in product or process development, including scale-up and technology transfer processes for both immediate and controlled release dosage forms preferred.
• Project Management experience with a minimum (1) year of experience.

• Understanding of Good Manufacturing Practices (GMP) and regulatory compliance.
• Lead projects of moderate to high complexity in scope and compliance-related challenges to implementing processes to meet changing regulations.
• Proficiency using Microsoft (MS) Office applications.
• Good critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.
• Self-starter, mature, independent, and detailed oriented.
• Ability to work in a fast-paced, results oriented, and structured environment.
• Experience leading projects related to process development including scale-up production activities.
• Effective time management, multi-tasking and prioritization skills to effectively run multiple projects.
• Lead by example.
• Courages and assumes challenges in a risk based approaches.
• Transparent and knowledgeable in presenting project updates daily.
• Diligent in team meetings and discussions.
• Collaborate across multiple departments to reach goals and objectives.
• Inclusive with communication styles and ideas.
• Conscientious to fellow peers with work load requirements.
• Coordinate and lead weekly meetings with customers.
• Fast and focused execution of tasks will be required at time.
• Build helpful ideas to increase production efficiencies.
• Technical skill information transferred to supporting departments.
• Participate and support audit participation and interaction for regulatory agencies.
• Develop and transform learning to peers with technical and mechanical result oriented aptitudes.
• Written communication skills expected and presentation will be expected.