Location: Remote
Company: Apogee Therapeutics
development. This role will report to the Senior Vice President of Quality Control and Analytical Development. Responsibilities Manage analytical method development, characterization and Quality Control testing at contract testing labs and CDMOs Develop phase-appropriate methods for drug substance/drug product characterization and release testing, including qualification and validation activities Oversee stability studies and comparability programs Author or review study protocols and reports Work with Quality Assurance to help build and maintain a robust QC infrastructure Execute strategies for moving products from early to late stage and commercial development Work closely with Manufacturing
& Development partners within Apogee Tech Ops, as well as external stakeholders, to execute analytical development and Quality Control activities according to program needs Required Skills Advanced degree in a relevant discipline (e.
g. analytical chemistry, biochemistry or related field) 10+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, and cell-based bioassays Excellent communication skills with an ability to collaborate effectively across functional lines Ability to work independently and
multi-task in a fast-moving organization Availability to participate in calls across multiple international time zones Successfully exhibit Apogee's C.
O. R. E. values: Caring, Original, Resilient and Egoless Ability and willingness to travel up to 25%
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs entail roles focused on ensuring that products or services meet established standards and customer expectations. People in QA positions are responsible for designing testing processes, creating test plans, identifying defects, and preventing defects by examining the production process. They aim to enhance product reliability and actively work to maintain quality consistency. QA roles often require keen attention to detail, strong problem-solving skills, and an understanding of both product specifications and customer needs. QA is an integral part of product development and maintenance, bridging the gap between the manufacturing processes and the end users to ensure a satisfactory experience.
Quality Assurance (QA) jobs involve the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met. The primary goal is to identify defects and issues before the product reaches the customer, thereby ensuring customer satisfaction and maintaining the reputation of an organization. QA roles often require attention to detail, strong problem-solving skills, and a good understanding of industry-specific regulations and standards. These jobs can vary widely, from software testing to food safety inspection, but they universally function as a critical checkpoint in the production and delivery process of goods or services.
