Lead Technical Services Scientist

Alternative Resources Company, an Openwork Company; South Carolina; On-site; USD 110,000 - 130,000; Full time

Job summary

Alternative Resources Company, an Openwork Company, seeks a Lead Technical Services Scientist to provide technical and people leadership for new liquid pharmaceutical products. You will own development manufacturing processes, lead critical deviation investigations, and oversee exhibit batch manufacturing with cross-functional collaboration.

The role supervises the Development Technical Services team, serves as the primary technical escalation point for operations, and drives scale-up strategies

Qualifications

• Bachelor’s degree in engineering or science; pharma manufacturing experience preferred.
• Strong English communication, both written and verbal.
• Excellent technical writing, detail orientation, and presentation skills.
• Ability to work under pressure, lead teams, and meet commitments.

Responsibilities

• Lead and direct Technical Services Scientists in development manufacturing and tech transfer.
• Serve as scientific/technical lead for development products and exhibit batches; define control strategies.
• Provide packaging study support and author protocols and reports for development products.
• Prepare and review technical documents for exhibit batches and regulatory filings (eCTD sections).
• Assess process capability and manufacturing readiness for exhibit batches and new products.
• Evaluate equipment/facility capabilities; define URS with Engineering for new/modified equipment.
• Support validation activities with protocols and reports aligned to processes and regulatory expectations.
• Collaborate with Operations, Quality, Engineering, Validation, Maintenance, Regulatory, and R&D on troubleshooting and investigations.
• Monitor project progress, manage resources, and communicate risks to leadership.

Skills

Leadership

Scientific writing

Analytical skills

Communication

Project management

Education

Bachelor's degree

Job description

The Lead Technical Services Scientist provides technical and people leadership for all new liquid pharmaceutical products. This role is responsible for ensuring the safe, compliant, efficient, and robust manufacture for development products through process ownership, leading the investigation of critical manufacturing deviations, and oversight of exhibit batch manufacturing.

This position has direct supervisory responsibility for the Development Technical Services team and serves as the primary technical escalation point for manufacturing operations.

Responsibilities:

• Effectively lead and direct Technical Services Scientists in support of manufacturing process development for new products and technology transfer activities.
• Serve as the scientific and technical lead for assigned development products, ensuring clear process understanding with defined control strategies and successful execution of exhibit batches. Propose scale-up strategy to establish robust manufacturing processes suitable for commercial production, and identification and mitigation of technical risks.
• Provide technical support to the Technical Services Packaging group as needed, including development and execution of packaging studies, authoring protocols and reports, and supporting investigations related to packaging processes for development products
• Generate, review, and approve technical documentation to support exhibit batch manufacturing and regulatory filings, including FDA submission documents (e.g., eCTD sections), batch records with side-by-side comparisons, protocols, reports, change controls, and other project-related documentation.
• Assess process capability and manufacturing readiness to support exhibit batch manufacturing as applicable to new products.
• Assess current manufacturing equipment and facility capabilities to support new process development and scale-up. Identify gaps or limitations, define the need for new or modified equipment, and collaborate with Engineering during development of User Requirement Specifications (URS) to ensure equipment design meets process requirements.
• Support validation groups during equipment validation/qualification activities by providing scientific input, authoring or reviewing validation protocols and reports, and ensuring alignment with proposed manufacturing processes for development projects and regulatory expectations.
• Collaborate closely with key cross-functional areas (i.e., Operations, Quality, Engineering, Validation, Maintenance, Regulatory, and R&D) during manufacturing process troubleshooting and investigations. Apply sound scientific judgment and technical expertise to develop and recommend effective solutions.
• Monitor progress of assigned projects, communicate status and risks to management, and proactively resolve issues. Effectively manage and coordinate resources to meet project timelines, quality standards, and company objectives.
• Ensure staff are adequately trained to perform job assignments in compliance with cGMP requirements. Identify, develop, and maintain relevant training materials (e.g., SOPs, WIs, protocols) and provide ongoing technical guidance to fully develop team capabilities and performance.
• Participate in personnel-related activities in collaboration with management, including interviewing, hiring, onboarding, coaching, and mentoring of Scientists and supporting staff.
• Regularly review staff performance and actively support professional development to enhance individual effectiveness and overall team performance.

Qualifications:

• Bachelor’s Degree in engineering or science (i.e., Pharmaceutical, Chemistry, Biology) plus a minimum of 8 years of pharmaceutical manufacturing experience. Or equivalent combination of education and experience. Knowledge of pharmaceutical GMPs and regulatory requirements (FDA, DEA, OSHA). Oral liquid pharmaceutical experience preferred
• Competent in English with strong written and verbal communication skills. Strong initiative and integrity as well as technical writing skills with attention to detail. Exceptional presentation and analytical skills.
• Ability to work in a team environment as well as independently. Ability to prioritize, organize, give appropriate attention to detail, and work effectively with minimal supervision including strong follow-up skills, and the ability to provide timely closure of assigned tasks is required.
• Knowledge of and experience in pharmaceutical manufacturing and packaging processes.
• Strong customer orientation; ability to develop relationships and effectively influence at all levels internally (e.g. management teams) and externally (e.g. contractors).
• Ability to work flexible hours.

Base salary range: $110,000- 130,000 per year. This is the anticipated salary range for fully qualified candidates. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry, education, etc.