Sr. Scientific Specialist - Specification Generation

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Sr. Scientific Specialist - Specification Generation is accountable for driving results in a fast-paced environment by effectively performing activities of varying complexity and ensures quality and compliance with applicable regulatory requirements. These activities include generation of specifications to support manufacturing and packaging activities, review of test procedures, maintaining current compendia and regulatory requirements, consulting on quality and compliance issues, and maintaining specification and test procedure supporting documentation. The position will provide guidance and mentoring for other employees and assist with the development of SOPs and company improvement initiatives. The Sr. Scientific Specialist - Specification Generation is expected to interact with clients and participate in regulatory/client audits as needed.

On-Site Expectations

• 100% remote position.
• 1st Shift: Monday - Friday, 8:30am - 5:30pm.

Responsibilities

• Generation of raw material specifications, drug product specifications, and packaging component specifications to support manufacturing and packaging activities.
• Collaboration with multiple departments to determine the specification minimum test requirements and acceptance criteria based on supporting documentation and phase of drug product development.
• Performs review and approval for testing procedures of multiple scientific techniques.
• Ensures test procedures are sufficiently supported for its intended use and do not contradict existing specifications.
• Evaluates compendia changes to determine if existing specifications and test procedures are impacted, performs updates to meet current compendia requirements.
• Consults with clients.
• Assists with improvement initiatives as needed.
• Assists with development of SOPs or other quality documents.
• Maintains accurate files and records, including all supporting documentation for specifications and test procedures within the company’s electronic document control system.
• Provides expertise in implementing regulatory and compendia requirements to ensure compliance and quality.
• Complies with company policies and SOPs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related field with 8+ years of GMP related experience, or Master’s degree in related field with 5+ years of related experience, or equivalent educational and work experience.
• Prior cGMP, Pharmaceutical or CDMO experience required.

Knowledge, Skills, and Abilities

• Expert knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Excellent written and verbal communication skills.
• Excellent detail orientation and organizational skills required.
• Excellent skills in strategic planning, problem solving, and critical thinking.
• Knowledge of pharmaceutical analytical testing, and quality principles in a cGMP environment.
• Excellent knowledge of ICH and compendial guidelines.
• Actively provides growth opportunities and guidance to others. Sought and relied on for expertise.
• Good math skills.
• Good computer skills and knowledge of Microsoft Office products.
• Ability to be trained and to mentor.
• Ability to act independently.
• Ability to interact well with clients and regulatory agents.
• Ability to interact well with employees at all levels.
• Ability to act as a consultant.

Travel Expectations

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move assisted up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.